Relief: Product Information

RELIEF- pramoxine hydrochloride shampoo
Elanco US Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

KEY INGREDIENTS: Pramoxine Hydrochloride 1%, Omega-6 fatty acids, and colloidal oatmeal.

PRODUCT DESCRIPTION: Relief Shampoo is a soap-free cleansing formulation combining the soothing benefits of pramoxine and colloidal oatmeal. It contains Omega-6 fatty acids for nourishment of the skin.

INDICATIONS: For cleansing of the hair coat and temporary relief of itching, flaking and irritation.

DIRECTIONS: Shake well before use. Wet coat thoroughly. Apply sufficient Relief Shampoo to lather well into hair coat. Contact with the skin is important. When entire coat is treated, allow lather to remain for 5 to 10 minutes. Rinse thoroughly with water. May be used as often as necessary or as directed by your veterinarian.

CAUTIONS: For topical use on animals only. If redness or irritation persists or increases, discontinue use and contact your veterinarian. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

STORAGE: Store at room temperature. Protect from freezing.

Manufactured for Elanco US Inc.
Shawnee, KS 66216
DVM & Design, Relief, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2021 Elanco or its affiliates

DVM™

Elanco

90202901 LV2108

Principal Display Panel – 237 mL Bottle Label

Elanco

Relief™ SHAMPOO

For temporary relief of itching and
flaking on dogs, cats, and horses

1% Pramoxine HCl

WARNING: Keep out of reach of children.

Anti-itch

NET CONTENTS 237 mL (8 fl oz)

Principal Display Panel – 237 mL Bottle Label
(click image for full-size original)

Principal Display Panel – 355 mL Bottle Label

Elanco

Relief™ SHAMPOO

For temporary relief of itching and
flaking on dogs, cats, and horses

1% Pramoxine HCI

WARNING: Keep out of reach of children.

Anti-itch

NET CONTENTS 355 mL (12 fl oz)

Principal Display Panel – 355 mL Bottle Label
(click image for full-size original)
RELIEF
pramoxine hydrochloride shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10.8 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0015-1 1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC contains a BOTTLE, PLASTIC
1 237 mL in 1 BOTTLE, PLASTIC This package is contained within the BOTTLE, PLASTIC (58198-0015-1)
2 NDC:58198-0015-2 1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC contains a BOTTLE, PLASTIC
2 355 mL in 1 BOTTLE, PLASTIC This package is contained within the BOTTLE, PLASTIC (58198-0015-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2014
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Syn-Tech Chem. & Pharm. Co., Ltd. 656002532 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Groupe PARIMA Inc. 252437850 MANUFACTURE, PACK, ANALYSIS
Establishment
Name Address ID/FEI Operations
Tropichem Research Labs, LLC dba Vetio 603123068 MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 09/2021 Elanco US Inc.

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