Label: SUNBURN RELIEF- lidocaine hcl 0.5% gel
- NDC Code(s): 55910-177-34
- Packager: Old East Main CO
- 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 January 16, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
SUNBURN RELIEF
lidocaine hcl 0.5% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-177 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5.00 mg 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 ANHYDROUS (UNII: 8NLQ36F6MM) 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:55910-177-34 226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/30/2019 Labeler - Old East Main CO (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-177) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-177)