Label: REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC- menthol 1.5% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-100-04, 58133-100-12, 58133-100-15, 58133-100-16, view more58133-100-33, 58133-100-60, 58133-100-62 - 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 February 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not bandage tightly
- Directions
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Inactive ingredients
Aloe Barbadensis Leaf, Anthemis nobilis, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum, Matricaria chamomilla, Mentha Piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata, Triethanolamine.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 mL Label
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC
menthol 1.5% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 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) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EMU OIL (UNII: 344821WD61) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SALIX ALBA BARK (UNII: 205MXS71H7) ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) SORBITOL (UNII: 506T60A25R) TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-100-33 97.5 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2015 2 NDC:58133-100-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2014 3 NDC:58133-100-15 45 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2014 4 NDC:58133-100-12 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2014 5 NDC:58133-100-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2014 6 NDC:58133-100-60 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/10/2020 7 NDC:58133-100-62 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2014 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Registrant - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-100)