Label: NUMBIFY SMOOTH- lidocaine hcl spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69804-083-01, 69804-083-04, 69804-083-07 - 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 June 19, 2020
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- WARNINGS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NUMBIFY SMOOTH
lidocaine hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 50 mg in 1000 mg Inactive Ingredients Ingredient Name Strength PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) 11 mg in 1000 mg CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 1 mg in 1000 mg BENZYL ALCOHOL (UNII: LKG8494WBH) 10 mg in 1000 mg WATER (UNII: 059QF0KO0R) 239 mg in 1000 mg PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 689 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-083-07 28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/19/2020 2 NDC:69804-083-01 56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/19/2020 3 NDC:69804-083-04 113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/19/2020 Labeler - Ridge Properties (029478762) Establishment Name Address ID/FEI Business Operations Ridge Properties 029478762 manufacture(69804-083)
