TRURELIEF RUBITON RUB IT WHERE IT HURTS- menthol cream

TruRelief RUBITON Rub It Where It Hurts by

Drug Labeling and Warnings

TruRelief RUBITON Rub It Where It Hurts by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

TRURELIEF RUBITON RUB IT WHERE IT HURTS 
menthol cream

Product 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)