Revolt: Product Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 15 MG TUBE CARTON

For puppies ≤ 5 lbs in weight and at least 6 weeks of age and

kittens ≤ 5 lbs in weight and at least 8 weeks of age

Three single-dose tubes each containing 0.25 mL (15 mg) of selamectin

NDC 51072-097-01

0.25 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1577

Rev. 02/2020

REORDER NO: 17003

PRINCIPAL DISPLAY PANEL -- 15 MG TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 MG TUBE CARTON

For dogs 5.1-10 lbs in weight and at least 6 weeks of age

Three single-dose tubes each containing 0.25 mL (30 mg) of selamectin

NDC 51072-098-06

0.25 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1597

Rev. 02/2020

REORDER NO: 16009

PRINCIPAL DISPLAY PANEL -- 30 MG TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 45 MG TUBE CARTON

For cats 5.1-15 lbs in weight and at least 8 weeks of age

Three single-dose tubes each containing 0.75 mL (45 mg) of selamectin

NDC 51072-097-04

0.75 mL

Revolt™ (selamectin)

Administer once a month for

protection against fleas and

heartworm disease and

treatment and control of

hookworms, roundworms,

and ear mites

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1595

Rev. 02/2020

REORDER NO: 17004

PRINCIPAL DISPLAY PANEL -- 45 MG TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 MG [1 ML] TUBE CARTON

For cats 15.1-22 lbs in weight and at least 8 weeks of age

Three single-dose tubes each containing 1.0 mL (60 mg) of selamectin

NDC 51072-097-05

1.0 mL

Revolt™ (selamectin)

Administer once a month for

protection against fleas and

heartworm disease and

treatment and control of

hookworms, roundworms,

and ear mites

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1596

Rev. 02/2020

REORDER NO: 17006

PRINCIPAL DISPLAY PANEL -- 60 MG [1 ML] TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 MG [0.5 ML] TUBE CARTON

For dogs 10.1-20 lbs in weight and at least 6 weeks of age

Three single-dose tubes each containing 0.5 mL (60 mg) of selamectin

NDC 51072-098-07

0.5 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1598

Rev. 02/2020

REORDER NO: 16011

PRINCIPAL DISPLAY PANEL -- 60 MG [0.5 ML] TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 MG TUBE CARTON

For dogs 20.1-40 lbs in weight and at least 6 weeks of age

Three single-dose tubes each containing 1.0 mL (120 mg) of selamectin

NDC 51072-098-08

1.0 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1599

Rev. 02/2020

REORDER NO: 16013

PRINCIPAL DISPLAY PANEL -- 120 MG TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 240 MG TUBE CARTON

For dogs 40.1-85 lbs in weight and at least 6 weeks of age

Three single-dose tubes each containing 2.0 mL (240 mg) of selamectin

NDC 51072-098-09

2.0 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1600

Rev. 02/2020

REORDER NO: 16015

PRINCIPAL DISPLAY PANEL -- 240 MG TUBE CARTON
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 360 MG TUBE CARTON

For dogs 85.1-130 lbs in weight and at least 6 weeks of age

Three single-dose tubes each containing 3.0 mL (360 mg) of selamectin

NDC 51072-098-10

3.0 mL

Revolt™ (selamectin)

Administer once
a month to prevent
heartworm disease
and prevent and controlflea infestations

aurora pharmaceutical®

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only. Keep out of reach of children.

Approved by FDA under ANADA # 200-673

3 Doses

IN 40-1601

Rev. 02/2020

REORDER NO: 16017

PRINCIPAL DISPLAY PANEL -- 360 MG TUBE CARTON
(click image for full-size original)
REVOLT selamectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51072-097
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELAMECTIN (SELAMECTIN) SELAMECTIN 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51072-097-01 3 TUBE in 1 CARTON contains a TUBE
1 0.25 mL in 1 TUBE This package is contained within the CARTON (51072-097-01)
2 NDC:51072-097-02 6 TUBE3 TUBE in 1 CARTON contains a TUBE
2 NDC:51072-097-04 6 TUBE3 TUBE in 1 CARTON contains a TUBE
2 0.75 mL in 1 TUBE This package is contained within a CARTON (51072-097-02) and a CARTON (51072-097-04)
3 NDC:51072-097-03 6 TUBE3 TUBE in 1 CARTON contains a TUBE
3 NDC:51072-097-05 6 TUBE3 TUBE in 1 CARTON contains a TUBE
3 1.0 mL in 1 TUBE This package is contained within a CARTON (51072-097-03) and a CARTON (51072-097-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200673 08/26/2020
REVOLT selamectin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51072-098
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELAMECTIN (SELAMECTIN) SELAMECTIN 120 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51072-098-01 6 TUBE3 TUBE in 1 CARTON contains a TUBE
1 NDC:51072-098-06 6 TUBE3 TUBE in 1 CARTON contains a TUBE
1 0.25 mL in 1 TUBE This package is contained within a CARTON (51072-098-01) and a CARTON (51072-098-06)
2 NDC:51072-098-02 6 TUBE3 TUBE in 1 CARTON contains a TUBE
2 NDC:51072-098-07 6 TUBE3 TUBE in 1 CARTON contains a TUBE
2 0.5 mL in 1 TUBE This package is contained within a CARTON (51072-098-02) and a CARTON (51072-098-07)
3 NDC:51072-098-03 6 TUBE3 TUBE in 1 CARTON contains a TUBE
3 NDC:51072-098-08 6 TUBE3 TUBE in 1 CARTON contains a TUBE
3 1.0 mL in 1 TUBE This package is contained within a CARTON (51072-098-03) and a CARTON (51072-098-08)
4 NDC:51072-098-04 6 TUBE3 TUBE in 1 CARTON contains a TUBE
4 NDC:51072-098-09 6 TUBE3 TUBE in 1 CARTON contains a TUBE
4 2.0 mL in 1 TUBE This package is contained within a CARTON (51072-098-04) and a CARTON (51072-098-09)
5 NDC:51072-098-05 6 TUBE3 TUBE in 1 CARTON contains a TUBE
5 NDC:51072-098-10 6 TUBE3 TUBE in 1 CARTON contains a TUBE
5 3.0 mL in 1 TUBE This package is contained within a CARTON (51072-098-05) and a CARTON (51072-098-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200673 08/26/2020
Labeler — Aurora Pharmaceutical, Inc. (832848639)
Establishment
Name Address ID/FEI Operations
Aurora Pharmaceutical, Inc. 832848639 manufacture

Revised: 08/2020 Aurora Pharmaceutical, Inc.

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