Label: EXTRA STRENGTH FIRST AID- lidocaine hcl cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69804-052-01, 69804-052-04, 69804-052-07, 69804-052-08 - 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 13, 2017
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- Official Label (Printer Friendly)
- 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 FIRST AID
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-052 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 ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 75 mg in 1000 mg WITCH HAZEL (UNII: 101I4J0U34) 510 mg in 1000 mg PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 200 mg in 1000 mg COPAIBA OIL (UNII: 64VX45Y68N) 100 mg in 1000 mg NUTMEG OIL (UNII: Z1CLM48948) 75 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-052-08 14200 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/14/2017 2 NDC:69804-052-07 28500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/14/2017 3 NDC:69804-052-01 56700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/14/2017 4 NDC:69804-052-04 113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/14/2017 Labeler - ridge properties (029478762) Establishment Name Address ID/FEI Business Operations ridge properties 029478762 manufacture(69804-052)
