HERBAL FREEZE- menthol spray

HERBAL FREEZE by

Drug Labeling and Warnings

HERBAL FREEZE 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: arthritis, simple backaches, strains, bruises, and sprains

Warnings

For external use only. Do not use on wounds or damaged skin or with a heat source.  If pregnant or breastfeeding, consult a healthcare professional before use.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, symptoms clear up and occur again within a few days.

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

Purified Water, Ethyl Alcohol, Arnica Montana (Arnica) Flower Extract, Populus Balsimafora (Balsam Poplar) Bud Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Glycerin

Questions or Comments

1-877-239-4667

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERBAL FREEZE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-3385
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
POPULUS BALSAMIFERA LEAF BUD (UNII: 9CQ6C00G3C)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-3385-3	113.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/21/2016
2	NDC: 61577-3385-2	85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/29/2016

Labeler - SOMBRA COSMETICS INC. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra Cosmetics Inc.		097464309	manufacture(61577-3385) , label(61577-3385)