Label: FIRST AID AND BURN- benzalkonium chloride, lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0924-5701-01, 0924-5701-04, 0924-5701-09, 0924-5701-10, view more0924-5701-11, 0924-5701-12, 0924-5701-13 - Packager: Acme United Corporation
- 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 March 9, 2016
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INGREDIENTS AND APPEARANCE
FIRST AID AND BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5701 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 hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 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:0924-5701-04 10 in 1 BOX 1 NDC:0924-5701-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-5701-09 10 in 1 BOX 2 NDC:0924-5701-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-5701-10 12 in 1 BOX 3 NDC:0924-5701-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0924-5701-11 25 in 1 BOX 4 NDC:0924-5701-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:0924-5701-12 144 in 1 BOX 5 NDC:0924-5701-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 6 NDC:0924-5701-13 60 in 1 BOX 6 NDC:0924-5701-01 0.9 g in 1 PACKET; 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 01/27/2012 Labeler - Acme United Corporation (001180207) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(0924-5701)