Label: REAL TIME PAIN RELIEF CREAM- menthol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-600-04, 58133-600-07, 58133-600-12, 58133-600-15, view more58133-600-16, 58133-600-33, 58133-600-40 - 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 December 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions:
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Inactive ingredients:
Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.
- Package Label, Principal Display Panel and Drug Facts
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF CREAM
menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CAPSICUM FRUTESCENS WHOLE (UNII: 6XJX33L87P) ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER 940 (UNII: 4Q93RCW27E) CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF) WATER (UNII: 059QF0KO0R) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) PHENOXYETHANOL (UNII: HIE492ZZ3T) EMU OIL (UNII: 344821WD61) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) SALIX ALBA BARK (UNII: 205MXS71H7) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) 3,4-METHYLENEDIOXYBENZYL METHYLSULFONE (UNII: 4W601CSX19) CETYL ALCOHOL (UNII: 936JST6JCN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITOL (UNII: 506T60A25R) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-600-15 45 mL in 1 TUBE; Type 0: Not a Combination Product 01/30/2013 2 NDC:58133-600-07 210 mL in 1 TUBE; Type 0: Not a Combination Product 01/30/2013 3 NDC:58133-600-04 120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/30/2013 4 NDC:58133-600-12 354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/30/2013 5 NDC:58133-600-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/30/2013 6 NDC:58133-600-40 120 mL in 1 TUBE; Type 0: Not a Combination Product 01/30/2013 7 NDC:58133-600-33 98 mL in 1 TUBE; Type 0: Not a Combination Product 01/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/30/2013 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(58133-600)