OTC Medication Information: A Breath of Fresh Air

A BREATH OF FRESH AIR- 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, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Betaine, Acer Saccharum (Sugar Maple) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Morus Alba Bark Extract, Houttuynia Cordata Extract, Sodium Hyaluronate, Fragrance, Ledum Palustre Extract, Achillea Millefolium Extract, Saururus Chinensis Extract, Artemisia Absinthium Extract, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Gentiana Lutea Root Extract

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. Remove mask from the pouch and gently unfold. Step 2. Apply mask to cleansed skin and smooth to fit contours of face. Step 3. Leave on for 10~15 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)

A BREATH OF FRESH AIR
witch hazel patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69424-280
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Witch Hazel (WITCH HAZEL) Witch Hazel 0.025 mg in 25 mL
Inactive Ingredients
Ingredient Name Strength
Water
Butylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69424-280-01 25 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 (69424-280)

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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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