Label: SUNBURN RELIEF GEL- lidocaine hcl gel
- NDC Code(s): 69842-909-34
- Packager: CVS
- 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 September 27, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- disclaimer
- principal display panel
-
INGREDIENTS AND APPEARANCE
SUNBURN RELIEF GEL
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-909 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5.05 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) MENTHOL (UNII: L7T10EIP3A) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-909-34 226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/31/2018 Labeler - CVS (062312574) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(69842-909) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(69842-909)