Label: EXTRA STRENGTH PRETAT- lidocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69804-001-01, 69804-001-04, 69804-001-07 - 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 April 28, 2020
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- DOSAGE & ADMINISTRATION
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- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PRETAT
lidocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-001 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 PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) 11 mg in 1000 mg WATER (UNII: 059QF0KO0R) 69 mg in 1000 mg COPAIBA OIL (UNII: 64VX45Y68N) 180 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 689 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-001-01 56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/20/2015 2 NDC:69804-001-04 113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/07/2015 3 NDC:69804-001-07 28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/08/2015 Labeler - Ridge Properties (029478762) Establishment Name Address ID/FEI Business Operations Ridge Properties 029478762 manufacture(69804-001)
