NDC | 58133-555-03, 58133-555-12 |
Set ID | 62fb27de-beb4-8bed-e053-2991aa0a6ae1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cosmetic Specialty Labs, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- 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:
-
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
-
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)