Label: CVS ANTISEPTIC WASH- benzalkonium chloride and lidocaine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-256-39 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 8, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Uses
- to help reduce the risk of infection in minor cuts scrapes and burns
- for the temporary relief of pain and itching associated with minor cuts, scrapes and burnsDirections
- adults and children 2 years 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: Do not use, consult a doctor
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WARNINGS
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 burns
Stop use and ask a doctor if - condition worsens - symptoms
persist for more than 7 days, or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center immediately.
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DOSAGE & ADMINISTRATION
Directions
- adults and children 2 years 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: Do not use, consult a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS ANTISEPTIC WASH
benzalkonium chloride and lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-256 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLOXAMER 188 (UNII: LQA7B6G8JG) EDETATE DISODIUM (UNII: 7FLD91C86K) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-256-39 177 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333A 07/08/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture
