Label: FIRST AID ONLY FIRST AID/ BURN- benzalkonium chloride, lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0924-5711-01, 0924-5711-02, 0924-5711-03, 0924-5711-04, view more0924-5711-05, 0924-5711-06, 0924-5711-07, 0924-5711-08, 0924-5711-09, 0924-5711-10, 0924-5711-11, 0924-5711-12, 0924-5711-13, 0924-5711-14 - Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 59898-902
- 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 22, 2020
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- Active ingredients
- Purpose
- Uses
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Warnings
For external use only.
Do not use
▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns - Other information
- Directions
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY FIRST AID/ BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5711(NDC:59898-902) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-100 STEARATE (UNII: YD01N1999R) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5711-04 10 in 1 CARTON 04/08/2019 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-5711-02 6 in 1 CARTON 04/08/2019 2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-5711-03 6 in 1 BAG 04/08/2019 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0924-5711-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 04/08/2019 5 NDC:0924-5711-05 10 in 1 CARTON 04/08/2019 5 0.9 g in 1 PACKET; Type 0: Not a Combination Product 6 NDC:0924-5711-06 12 in 1 CARTON 04/08/2019 6 0.9 g in 1 PACKET; Type 0: Not a Combination Product 7 NDC:0924-5711-07 20 in 1 CARTON 04/08/2019 7 0.9 g in 1 PACKET; Type 0: Not a Combination Product 8 NDC:0924-5711-08 20 in 1 CARTON 04/08/2019 8 0.9 g in 1 PACKET; Type 0: Not a Combination Product 9 NDC:0924-5711-09 25 in 1 CARTON 04/08/2019 9 0.9 g in 1 PACKET; Type 0: Not a Combination Product 10 NDC:0924-5711-10 25 in 1 CARTON 04/08/2019 10 0.9 g in 1 PACKET; Type 0: Not a Combination Product 11 NDC:0924-5711-11 50 in 1 CARTON 04/08/2019 11 0.9 g in 1 PACKET; Type 0: Not a Combination Product 12 NDC:0924-5711-12 60 in 1 CARTON 04/08/2019 12 0.9 g in 1 PACKET; Type 0: Not a Combination Product 13 NDC:0924-5711-13 144 in 1 CARTON 04/08/2019 13 0.9 g in 1 PACKET; Type 0: Not a Combination Product 14 NDC:0924-5711-14 144 in 1 CARTON 04/08/2019 14 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 part348 04/08/2019 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-5711) , repack(0924-5711) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-5711) , repack(0924-5711)