Label: ALOE VERA GEL- lidocaine hcl gel
- NDC Code(s): 63941-005-34
- Packager: Valu Merchandisers, CO.
- 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 11, 2023
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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
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Bayer, distributor of Solarcaine Cool Aloe Burn Relief Formula
Proudly distributed by: Valu Merchandisers, Co.
5000 Kansas Ave, Kansas City, KS 66106
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www.bestchoicebrand.com
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Call 1-844-292-1113 for more product information.
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INGREDIENTS AND APPEARANCE
ALOE VERA GEL
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.5 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 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:63941-005-34 226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/14/2017 Labeler - Valu Merchandisers, CO. (868703513) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63941-005) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63941-005)