KALAHARI MELON MOISTURIZING MASK: Package Insert and Label Information

KALAHARI MELON MOISTURIZING MASK- witch hazel patch
SANSUNG LIFE & SCIENCE CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, 1,2-Hexanediol, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Cocos Nucifera (Coconut) Fruit Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Betaine, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Fragrance, Citrullus Lanatus (Watermelon) Seed Oil, Houttuynia Cordata Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Ledum Palustre Extract, Saururus Chinensis Extract, Artemisia Absinthium Extract, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Achillea Millefolium Extract, Xylitylglucoside, Anhydroxylitol, Gentiana Lutea Root Extract, Xylitol, Hydrogenated Lecithin, Panthenol, Niacinamide, Tocopheryl Acetate, Retinyl Palmitate, Biotin, Ascorbic Acid, Folic Acid, Dipotassium Glycyrrhizate, Ceramide 3, Glyceryl Linolenate, Glyceryl Linoleate, Glyceryl Arachidonate

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. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indication and usage: Step 1. Take out mask from pouch and remove protective film from either side of the mask. Step 2. Apply to cleansed face and smooth to fit facial contours. Step 3. Leave mask on face for 20~25 minutes. Step 4. Discard mask and lightly pat face to help absorb serum into skin.

DOSAGE & ADMINISTRATION

Dosage and administration: 2-3 times a week. Each mask is for one time use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello pack
(click image for full-size original)

KALAHARI MELON MOISTURIZING MASK
witch hazel patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69424-240
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Witch Hazel (WITCH HAZEL) Witch Hazel 0.03 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water
Butylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69424-240-01 30 mL in 1 CELLO PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/01/2015
Labeler — SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Registrant — SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Establishment
Name Address ID/FEI Operations
SANSUNG LIFE & SCIENCE CO., LTD. 689524929 manufacture (69424-240)

Revised: 05/2015 SANSUNG LIFE & SCIENCE CO., LTD.

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