Label: SIMMYUNGSAENGMOSU HAIR TONIC- alpha-tocopherol acetate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 32819-1001-1, 32819-1001-2 - Packager: Simmyung Pharmaceutical Co Ltd
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 4, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
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Keep out of Reach of Children
Stop use and ask a doctor if
- chest pain, rapid heartbeat, faintness or dizziness occurs
- your hands or feet swell
- scalp irritation or redness occurs
- May be harmful if used when pregnant or breast-feeding.
- Keep out of reach of children if swallowed, get medical help or Poison Control Center right away -
Indication & Usage
When using this product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some people have experienced changes in hair color and/or texture
- it takes time to regrow hair
- the amount of hair regrowth is different for each person. This product will not
work for everyone. -
Warnings
For external use only
Do not use
- your scalp is red, inflamed, infected, irritated, or painful
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- your hair loss is associated with childbirth
- you do not know the reason for your hair loss
- you are under 18 years of age. Do not use on babies and children Ask adoctor before use if you have heart disease -
Dosage & Administraion
- shake well before using product
- apply an appropriate amount all over scalp every day
- scrub and massage scalp using hands for helping to absorb product
Other information
- before use, read all information on carton and enclosed booklet
- store at controlled room temperature 1 to 30??br/>
- Do not store in hot locations or expose to sunlight
- Inactive Ingredient
- SimmyungSaengMoSu
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INGREDIENTS AND APPEARANCE
SIMMYUNGSAENGMOSU HAIR TONIC
alpha-tocopherol acetate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:32819-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE 3 mL in 150 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.75 mL in 150 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.45 mL in 150 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) ETHYLPARABEN (UNII: 14255EXE39) Product Characteristics Color brown (yellow brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32819-1001-2 1 in 1 BOX 1 NDC:32819-1001-1 150 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/02/2010 Labeler - Simmyung Pharmaceutical Co Ltd (557795393) Registrant - Simmyung Pharmaceutical Co Ltd (557795393) Establishment Name Address ID/FEI Business Operations Simmyung Pharmaceutical Co Ltd 557795393 manufacture
