Label: FIRST AID- benzalkonium chloride and lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69103-3553-1 - Packager: Provision Medical
- Category: HUMAN OTC DRUG LABEL
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 December 2, 2014
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
- Uses
- Warnings
- Do not use
- Directions
- Inactive Ingredients
- Principal Display Panel - Pouch Label
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INGREDIENTS AND APPEARANCE
FIRST AID
benzalkonium chloride and lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-3553 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 g lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine 5.0 mg in 1 g Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) alcohol (UNII: 3K9958V90M) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) petrolatum (UNII: 4T6H12BN9U) white wax (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69103-3553-1 0.9 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/02/2014 Labeler - Provision Medical (036936831) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(69103-3553)