Label: BERBEREX WOUND CLEANSER- benzethonium chloride liquid
- NDC Code(s): 52261-0500-1, 52261-0500-2, 52261-0500-3
- Packager: Cosco International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient/Purpose
- WARNINGS
- Do not use
- Ask doctor before use if you have
- Stop use and ask doctor if
- KEEP OUT OF REACH OF CHILDREN
-
Directions:
Adults and children 2 years of age and older:
- use to clean minor cut, scrapes, and burns by thoroughly flushing the affected area
- let air dry
- cover with adhesive bandage or sterile gauze
- apply a small amount of this product on the area 1 to 3 times daily
Children under 2 years of age: do not use, consult a doctor
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BERBEREX WOUND CLEANSER
benzethonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 5 g in 1000 mL BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1 g in 1000 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X) hydrogen peroxide (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-0500-1 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2015 2 NDC:52261-0500-2 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2015 3 NDC:52261-0500-3 473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/24/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/17/2015 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-0500) , label(52261-0500) , pack(52261-0500)