BerbereX Wound Cleanser: Package Insert and Label Information

BERBEREX WOUND CLEANSER- allantoin and benzethonium chloride solution
Cosmetic Specialty Labs, Inc.

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.

• Allantoin 0.5%
• Benzethonium Chloride 0.1%

PURPOSE

• Skin Protectant
• Antiseptic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center immediately.

USES

helps protect skin and supports healing of minor cuts,

scapes, bums and wounds, including pressure sores, diabetic

ulcers, cracked skin and lips. topical antiseptic to help decrease

the risk of skin infections

WARNINGS

for external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious bums

Stop use and ask a doctor if

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

DIRECTIONS

Adults and children 2years 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 2years of age

do not use, consult a doctor

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

BERBEREX WOUND CLEANSER allantoin, benzethonium chloride solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-055 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (ALLANTOIN) ALLANTOIN 5 g in 1000 mL BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 1 g in 1000 mL

Inactive Ingredients Ingredient Name Strength ALOE VERA WHOLE ALCOHOL HYDRASTIS CANADENSIS WHOLE Hydrogen Peroxide PANAX QUINQUEFOLIUS WHOLE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58133-055-04 118 mL in 1 BOTTLE None 2 NDC:58133-055-08 236 mL in 1 BOTTLE None 3 NDC:58133-055-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2013

Labeler — Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Operations
Cosmetic Specialty labs, Inc.		032973000	manufacture (58133-055)

Revised: 01/2014 Cosmetic Specialty Labs, Inc.