Label: REAL TIME PAIN RELIEF VEGAN SELECT- menthol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-555-03, 58133-555-12 - 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 January 17, 2018
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- 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, Arnica Montana Flower Extract, Butylene Glycol , Calendula officinalis, Caprylyl Glycol, Capsicum Frutescens Fruit Extract, Carbomer, Centaurea cyanus, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Fragrance, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum, Matricaria chamomilla, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Rubus Idaeus (Raspberry) Seed Oil, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tilia cordata, Triethanolamine.
- Package Label, Principal Display Panel and Drug Facts
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF VEGAN SELECT
menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-555 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) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 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) RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-555-03 90 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/30/2013 2 NDC:58133-555-12 355 mL in 1 BOTTLE, PLASTIC; 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(58133-555)