Label: SUNBURN PAIN RELIEF- lidocaine hydrochloride 0.5% gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 36800-883-06 - Packager: Top Care
- 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 June 26, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses for temporary relief of pain and itching due to
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNBURN PAIN RELIEF
lidocaine hydrochloride 0.5% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-883 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 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Diazolidinyl Urea (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Isopropyl Alcohol (UNII: ND2M416302) Menthol (UNII: L7T10EIP3A) Polysorbate 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-883-06 1 in 1 CARTON 02/12/2016 1 237 mL in 1 BOTTLE; 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 02/12/2016 Labeler - Top Care (006935977) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(36800-883) , label(36800-883)