Bio-Groom Ear-Care: Product Information

BIO-GROOM EAR-CARE- boric acid and salicylic acid solution
Bio-Derm Laboratories 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.

Drug Facts

Active Ingredient Purpose
Boric acid 0.80% Antibacterial
Salicylic acid 0.20% Antiseptic ear cleaner

Uses

to routinely remove dirt and dissolve ear wax buildup.

Warnings

For external use only on dogs and cats

Ask a veterinarian before use if your pet has

  • painful ear condition
  • discharge
  • broken or abraded skin

When Using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a veterinarian if

  • condition worsens or does not improve after use of this product as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well
  • apply generously to each ear. Gently massage ears until dirt and wax are dissolved.
  • Allow pet to shake its head to dispel accumulation and swab ears with cotton.
  • For best results, use twice a month or after each bath and before and after swimming or as directed by a veterinarian.

Inactive ingredients

water, isopropyl alcohol, polysorbate 60, eucalyptol.

Manufactured by
bio-derm®
LABORATORIES, INC.

P.O.BOX 8070,
LONGVIEW, TX 75607 USA

PRINCIPAL DISPLAY PANEL — 3.8L Bottle Label

BIO-GROOM ®

EAR CARE
NON-OILY NON-STICKY

EAR CLEANER

Gently cleans and dries the ear
canal. Removes excessive
wax build-up.

PRINCIPAL DISPLAY PANEL -- 3.8L Bottle Label
(click image for full-size original)
BIO-GROOM EAR-CARE
boric acid and salicylic acid solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46521-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BORIC ACID (BORIC ACID) BORIC ACID 0.8 mg in 100 mL
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.2 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
POLYSORBATE 60
EUCALYPTOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46521-003-04 118 mL in 1 BOTTLE None
2 NDC:46521-003-08 236 mL in 1 BOTTLE None
3 NDC:46521-003-01 29 mL in 1 BOTTLE None
4 NDC:46521-003-28 3800 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/10/1985
Labeler — Bio-Derm Laboratories Inc. (057405219)
Establishment
Name Address ID/FEI Operations
Bio-Derm Laboratories Inc. 057405219 MANUFACTURE

Revised: 06/2011 Bio-Derm Laboratories Inc.

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