Drug Labeling and Warnings

Drug Details [pdf]

ALWAYS PURE BETA PEEL- witch hazel solution 
DMS INTERNATIONAL 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.

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ACTIVE INGREDIENT

Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 0.08%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol Denat., Glycerin, Glycolic Acid, PEG/PPG-17/6 Copolymer, PEG-240/HDI Copolymer Bis-Decyltetradeceth-20Ether, Glycereth-26, Butylene Glycol, Sodium Lactate, Propylene Glycol, Sodium PCA, Citric Acid, Allantoin, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Salicylic Acid, Chlorphenesin, Lactic Acid, Malic Acid, Caprylyl Glycol, Ethylhexylglycerin, Arctium Lappa Root Extract, Nasturtium Officinale Extract, Salvia Officinalis (Sage) Extract, Pyruvic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Alcohol, PEG-60 Almond Glycerides, Aloe Barbadensis Leaf Juice, Potassium sorbate, Tartaric Acid, Sodium Benzoate, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

KEEP OUT OF REACH OF CHILDREN

Keep product out of reach of infants and children.

INDICATIONS & USAGE

Indications & usage: Use once a week, take proper amount it with syringe into the small glass bowl then apply it evenly on the whole face, except near eye and mouth, with cotton swab or pack brush. Clean face using foam cleansing products after 2 minute, then wass off with water.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ALWAYS PURE BETA PEEL 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.08 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-020-01100 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201601/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
DMS INTERNATIONAL CO., LTD.688309194manufacture(70265-020)

Revised: 8/2019
 
DMS INTERNATIONAL CO., LTD.