FREEZE 24 7 INTENSE HYDRATING FACE MASK- witch hazel patch

Freeze 24 7 Intense Hydrating Face Mask by

Drug Labeling and Warnings

Freeze 24 7 Intense Hydrating Face Mask by is a Otc medication manufactured, distributed, or labeled by Summit C&T LLC, SANSUNG LIFE & SCIENCE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 0.1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Methylpropanediol, Glycerin, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Dipropylene Glycol, 1,2-Hexanediol, Betaine, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Lactobacillus/Leuconostoc/Cocos Nucifera (Coconut) Fruit Extract, Polysorbate 60, Sorbitan Isostearate, Xanthan Gum, Xylitylglucoside, Adenosine, Anhydroxylitol, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Houttuynia Cordata Extract, Ledum Palustre Extract, Saururus Chinensis Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xylitol, Achillea Millefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Gentiana Lutea Root Extract, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine, Cysteine, Methionine, Acetyl Hexapeptide-37

PURPOSE

Purpose: Skin protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. Use immediately after opening. Caution: Store in cool and dry place. Use Immediately after opening.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

How to use: 1. Remove mask from the sachet and gently unfold. 2. Peel off the protective paper from one side of the mask. 3. Apply the mask to cleansed and dry face, fitting it to the curves around the eyes, nose and mouth. 4. Once fully applied to face, remove the protective film from the outside of the mask. 5. Leave on for 20-25 minutes then discard. 6. Gently pat the face with clean fingertips until the remaining serum is fully absorbed. No need to rinse.

DOSAGE & ADMINISTRATION

For Best Results: Use 2-3 times a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FREEZE 24 7 INTENSE HYDRATING FACE MASK 
witch hazel patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70592-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	0.03 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methylpropanediol (UNII: N8F53B3R4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70592-020-02	1 in 1 CARTON	03/02/2016
1	NDC: 70592-020-01	30 mL in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/02/2016

Labeler - Summit C&T LLC (080194385)

Registrant - Summit C&T LLC (080194385)

Establishment
Name	Address	ID/FEI	Business Operations
Summit C&T LLC		080194385	repack(70592-020)

Establishment
Name	Address	ID/FEI	Business Operations
SANSUNG LIFE & SCIENCE CO., LTD.		689524929	manufacture(70592-020)