RE-LEVE by SOMBRA COSMETICS INC. RE-LEVE- menthol gel

RE-LEVE by

Drug Labeling and Warnings

RE-LEVE by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 4%

Purpose

Purpose
External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

Warnings

Keep out of reach of children.  For external use only. Avoid contact with eyes and mucous membranes, wounds or damaged skin.  Do not use with heating pads.

Stop uses and ask a doctor if: Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

Directions

Adult and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub until gel is absorbed, children under 2 years of age: consult your doctor.

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, emu oil, citrus aurantium dulcis (orange) peel oil, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, sodium hydroxymethylglycinate

Questions or Comments?  Orders: 

Call toll-free:  1-844-303-0037, 155 NE Court St.-152, Prineville, OR, 97754.  www.allforu.org.  Alcohol-free product made in USA.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RE-LEVE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-3242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.06 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
CITRUS MAXIMA SEED (UNII: 083X55C543)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
SODIUM CARBONATE (UNII: 45P3261C7T)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
LEMON OIL (UNII: I9GRO824LL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-3242-4	113.6 g in 1 JAR; Type 0: Not a Combination Product	10/05/2016
2	NDC: 61577-3242-5	113.6 g in 1 TUBE; Type 0: Not a Combination Product	10/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/05/2016

Labeler - SOMBRA COSMETICS INC. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS INC.		097464309	manufacture(61577-3242) , label(61577-3242)