Label: LIDOCAINE PLUS MAXIMUM STRENGTH PAIN RELIEVING CREAM- lidocaine hydrochloride cream
- NDC Code(s): 58443-0123-3
- Packager: Prime Enterprises Inc.
- 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 July 15, 2020
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- Lidocaine Plus Maximum Strength Pain Relieving Cream
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INGREDIENTS AND APPEARANCE
LIDOCAINE PLUS MAXIMUM STRENGTH PAIN RELIEVING CREAM
lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 39.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength LAURETH-7 (UNII: Z95S6G8201) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 940 (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0123-3 118 mL in 1 TUBE; Type 0: Not a Combination Product 03/02/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/02/2007 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0123) , manufacture(58443-0123) , label(58443-0123) , analysis(58443-0123)