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.

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BIO-GROOM®
EAR-CARE™
NON OILY-NON STICKY
EAR CLEANER

Drug Facts

Active IngredientPurpose
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

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
BIO-GROOM   EAR-CARE
boric acid and salicylic acid solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46521-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID0.8 mg  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EUCALYPTOL (UNII: RV6J6604TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46521-003-04118 mL in 1 BOTTLE
2NDC:46521-003-08236 mL in 1 BOTTLE
3NDC:46521-003-0129 mL in 1 BOTTLE
4NDC:46521-003-283800 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/10/1985
Labeler - Bio-Derm Laboratories Inc. (057405219)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Derm Laboratories Inc.057405219MANUFACTURE

Revised: 6/2011
Document Id: f7b35fb6-d11e-4524-8284-e90deeac4385
Set id: 39e164d2-84f2-4bfc-be0d-3876a6e5c66a
Version: 1
Effective Time: 20110610
 
Bio-Derm Laboratories Inc.