Label: ALOE VERA GEL- lidocaine hcl, menthol gel
- NDC Code(s): 41250-747-43
- Packager: Meijer Distribution
- 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 April 22, 2022
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- 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
- Adverse Reactions Section
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INGREDIENTS AND APPEARANCE
ALOE VERA GEL
lidocaine hcl, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-747 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4.97 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.4 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:41250-747-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/29/2016 Labeler - Meijer Distribution (006959555) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41250-747) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41250-747)