BERBEREX WOUND CLEANSER- benzethonium chloride liquid

BerbereX Wound Cleanser by

Drug Labeling and Warnings

BerbereX Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient/Purpose

Allantoin 0.5%........................Skin Protectant

Benzethonium Chloride............Antiseptic

Uses

• helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips
• topical antiseptic to help decrease the risk of skin infections

WARNINGS

Warnings  For external use only.

Do not use 

• in large quantities, particularly over raw surfaces or blistered areas

Ask doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask doctor if

• condition worsens
• symptons persist for more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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

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:

Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L., Water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERBEREX WOUND CLEANSER 
benzethonium chloride liquid

Product 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)