SOMBRA PLUS CBD 1000MG COOL THERAPY- menthol gel

SOMBRA PLUS CBD 1000MG COOL THERAPY by

Drug Labeling and Warnings

SOMBRA PLUS CBD 1000MG COOL THERAPY by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics Inc., Sombra COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 6%

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: strains, bruises, and sprains

Warnings

For external use only. Do not use on wounds or damaged skin or with heat source. If you are pregnant or breastfeeding, consult a healthcare professional before use. When using this product: Avoid bandaging tightly, avoid contact with eyes, keep out of reach children

Directions

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

Inactive Ingredients

aloe barbadensis leaf juice, camellia sinensis (green tea) leaf extract, Cannabidiol (isolate), caprylyl glycol, carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, decyl glucoside, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbonate, Filipendula ulmaria (queen of the prairie) flower extract, yucca schidigera root extract,

Questions or Comments

1-800-225-3963

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOMBRA PLUS CBD 1000MG COOL THERAPY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-7100
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)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CARBONATE (UNII: 45P3261C7T)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
LEMON OIL (UNII: I9GRO824LL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CANNABIDIOL (UNII: 19GBJ60SN5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-7100-2	56.7 g in 1 JAR; Type 0: Not a Combination Product	05/20/2022
2	NDC: 61577-7100-4	113.4 g in 1 JAR; Type 0: Not a Combination Product	05/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/20/2022

Labeler - Sombra Cosmetics Inc. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra COSMETICS INC		097464309	manufacture(61577-7100) , label(61577-7100)