Label: REG- lidocaine hydrochloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73663-001-04 - Packager: TG Ventureprises LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 5, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- Numb Gel 5.0%
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INGREDIENTS AND APPEARANCE
REG
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73663-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 4 g in 100 g CUCUMBER JUICE (UNII: 61845009SP) 0.1 g in 100 g CARBOMER 940 (UNII: 4Q93RCW27E) 2 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 2 g in 100 g CAFFEINE (UNII: 3G6A5W338E) 0.25 g in 100 g 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) 5 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2 g in 100 g Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73663-001-04 120 g in 1 JAR; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/01/2020 Labeler - TG Ventureprises LLC (117373103) Establishment Name Address ID/FEI Business Operations Debut Development LLC 079705544 manufacture(73663-001)
