Label: EXTRA STRENGTH NUMBING GEL- lidocaine hcl gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69804-021-09, 69804-021-10, 69804-021-11, 69804-021-12 - Packager: Ridge Properties
- 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 9, 2017
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- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH NUMBING GEL
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1000 mg Inactive Ingredients Ingredient Name Strength WITCH HAZEL (UNII: 101I4J0U34) 315 mg in 1000 mg PHENOXYETHANOL (UNII: HIE492ZZ3T) 5 mg in 1000 mg AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE) 110 mg in 1000 mg CALCIUM HYDROXIDE (UNII: PF5DZW74VN) 5 mg in 1000 mg ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 525 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-021-09 14200 mg in 1 JAR; Type 0: Not a Combination Product 01/13/2017 2 NDC:69804-021-10 28500 mg in 1 JAR; Type 0: Not a Combination Product 01/13/2017 3 NDC:69804-021-11 56700 mg in 1 JAR; Type 0: Not a Combination Product 01/13/2017 4 NDC:69804-021-12 113400 mg in 1 JAR; Type 0: Not a Combination Product 01/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/13/2017 Labeler - Ridge Properties (029478762) Establishment Name Address ID/FEI Business Operations Ridge Properties 029478762 manufacture(69804-021)
