Label: MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS- lidocaine hydrochloride 4.00% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64048-5002-4 - Packager: Product Quest Mfg.
- 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 May 29, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- Keep out of the reach of children
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS
lidocaine hydrochloride 4.00% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-5002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) OAT (UNII: Z6J799EAJK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Caprylyl Glycol (UNII: 00YIU5438U) Chlorphenesin (UNII: I670DAL4SZ) Dimethyl Isosorbide (UNII: SA6A6V432S) Glycerin (UNII: PDC6A3C0OX) Isopropyl Alcohol (UNII: ND2M416302) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 20 (UNII: 7T1F30V5YH) Propanediol (UNII: 5965N8W85T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64048-5002-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/08/2016 Labeler - Product Quest Mfg. (927768135) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(64048-5002) , label(64048-5002)