Label: ALOE VERA GEL- lidocaine hcl, menthol gel
- NDC Code(s): 72476-747-43
- Packager: Retail Business Services, LLC
- 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 January 9, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- 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
ALOE VERA GEL
lidocaine hcl, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-747 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 7 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLYSORBATE 20 (UNII: 7T1F30V5YH) glycerin (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) SULISOBENZONE (UNII: 1W6L629B4K) TROLAMINE (UNII: 9O3K93S3TK) BENZYL ALCOHOL (UNII: LKG8494WBH) phenoxyethanol (UNII: HIE492ZZ3T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-747-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/24/2021 Labeler - Retail Business Services, LLC (967989935) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72476-747) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72476-747)