Label: PAIN RELIEF CREAM TOPICAL ANALGESIC- menthol 6% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-222-03 - Packager: Cosmetic Specialty labs, 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 October 31, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
for external use only
When using this product
- use only as directed
- do not bandage tightly
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged skin
- Directions
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana, Butylene glycol, Calendula officinalis (Marigold), Capryl glycol, Calpsicum grutescens, Carbomer, Cantharius tinctorious (Safflower) Seed Oil, Centaureacyanus (Cornflower), Cetearyl alcohol, Cetyl alcohol, Chamomila recutita (Matricaria Chamomila), Coriandrum sativum (Coriander), Hamamelis virginiana (Witch Hazel), Bark/Leaf/Twig, Hypericum perforatum (St. John's Wort), Industrial Hemp geed oil, Methylsulfonylmethane, Phenoxyethanol, Purified water,Salix alba (Willow Bark), SD Alcohol40, Sorbitol, Tetrasodium EDTA, Tilla cordata (Lime Tree), Triethanolamine
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF CREAM TOPICAL ANALGESIC
menthol 6% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPSICUM (UNII: 00UK7646FG) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CORIANDER OIL (UNII: 7626GC95E5) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SALIX ALBA BARK (UNII: 205MXS71H7) ISOPROPYL ALCOHOL (UNII: ND2M416302) SORBITOL (UNII: 506T60A25R) TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) HEMP (UNII: TD1MUT01Q7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) 3-((3-CHLOROPHENYL)(4-(METHYLSULFONYL)PHENYL)METHYLENE)DIHYDRO-2(3H)-FURANONE, (3Z)- (UNII: 920350682Z) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-222-03 81 mL in 1 TUBE; Type 0: Not a Combination Product 10/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/31/2018 Labeler - Cosmetic Specialty labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty labs, Inc. 032973000 manufacture(58133-222)