TRURELIEF RUBITON RUB IT WHERE IT HURTS- menthol cream 
Cosmetic Specialty Labs, Inc.

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.

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Active Incredient

Menthol, 3.0%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Warnings

for external use only

When using this prodcutuse only as directed do not bandage tightly or use with heating pad avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions:

Adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

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

Principal Display Panel

TRURELIEF RUBITON RUB IT WHERE IT HURTS 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-451
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-451-0488 mL in 1 TUBE; Type 0: Not a Combination Product02/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/08/2022
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-451) , pack(58133-451) , label(58133-451) , analysis(58133-451)

Revised: 2/2022
Document Id: d7875d8c-dbc2-0f31-e053-2a95a90a5030
Set id: d7876228-8dd7-e3bd-e053-2a95a90a7925
Version: 1
Effective Time: 20220208
 
Cosmetic Specialty Labs, Inc.