Label: TRURELIEF RUBITON RUB IT WHERE IT HURTS- menthol cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 58133-451-04 - 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 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Incredient
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions:
-
Inactive ingredients
Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana Flower Extract, Butylene Glycol, Calendula officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.
- Package Label
-
INGREDIENTS AND APPEARANCE
TRURELIEF RUBITON RUB IT WHERE IT HURTS
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-451 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPSICUM (UNII: 00UK7646FG) EMU OIL (UNII: 344821WD61) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CORIANDER OIL (UNII: 7626GC95E5) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) SALIX ALBA BARK (UNII: 205MXS71H7) EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER 940 (UNII: 4Q93RCW27E) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHAMOMILE (UNII: FGL3685T2X) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-451-04 88 mL in 1 TUBE; Type 0: Not a Combination Product 02/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/08/2022 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-451) , pack(58133-451) , label(58133-451) , analysis(58133-451)