SOMBRA COOL THERAPY
Sombra Cool Therapy Natural Pain Relieving Gel
87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3
HUMAN OTC DRUG LABEL
May 27, 2025
SOMBRA COSMETICS INC.
DUNS: 097464309
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MENTHOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains
DOSAGE & ADMINISTRATION SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Menthol USP 6%
OTC - PURPOSE SECTION
Purpose
Purpose
External Analgesic
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children
WARNINGS SECTION
Warnings
For external use only. Do not use on wounds or damaged skin.When using this product: avoid bandaging tightly, avoid contact with eyes,keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol
OTC - QUESTIONS SECTION
Questions or Comments
1-800-225-3963