Label: LID O CREME ROLL ON- lidocaine hcl, menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63788-111-25 - Packager: Pharma Natural, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 31, 2018
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Inactive ingredients
aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water
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INGREDIENTS AND APPEARANCE
LID O CREME ROLL ON
lidocaine hcl, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63788-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TRIDECETH-6 (UNII: 3T5PCR2H0C) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCOL STEARATE (UNII: 0324G66D0E) METHYLPROPANEDIOL (UNII: N8F53B3R4R) ALMOND OIL (UNII: 66YXD4DKO9) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-100 STEARATE (UNII: YD01N1999R) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63788-111-25 71 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2018 Labeler - Pharma Natural, Inc. (138059287)