DR.G A CLEAR AROMA SPOT TONER- salicylic acid liquid 
GOWOONSESANG COSMETICS 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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Dr. G A Clear Aroma Spot Toner

Active ingredient(s)

Salicylic acid 0.5%

Purpose(s)

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Sensitivity Test for a New User. Apply product sparingly to one or two small affected area during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information

  • store at controlled room temperature 59° - 86°F (15° - 30°C). Protect from freezing.

Inactive ingredients

ALCOHOL, WATER, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, SODIUM CITRATE, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, AGRIMONIA EUPATORIA EXTRACT, MAGNOLIA KOBUS BARK EXTRACT, CITRUS GRANDIS (GRAPEFRUIT) FRUIT EXTRACT, THUJOPSIS DOLABRATA BRANCH EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, BUTYLENE GLYCOL, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, HOUTTUYNIA CORDATA EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, CASTANEA SATIVA (CHESTNUT) SEED EXTRACT, QUERCUS ACUTISSIMA FRUIT EXTRACT, CHAMAECYPARIS OBTUSA WATER, ALOE BARBADENSIS LEAF JUICE, CARBONATED WATER, CITRUS AURANTIFOLIA (LIME) FRUIT EXTRACT, MENTHA ROTUNDIFOLIA LEAF EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, POLYPERFLUOROMETHYLISOPROPYL ETHER, OLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE, POLOXAMER 188, GLYCERIN, BUTYLENE GLYCOL, PROPYLENE GLYCOL, POTASSIUM CETYL PHOSPHATE, SODIUM CITRATE, CYCLODEXTRIN, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Package Label.Principal Display Panel

DR.G A CLEAR AROMA SPOT TONER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-060
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
TEA TREE OIL (UNII: VIF565UC2G)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-060-021 in 1 CARTON11/15/201401/10/2018
1NDC:51621-060-01150 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/15/201401/10/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Biocostec Co., Ltd.690407325manufacture(51621-060)

Revised: 1/2018
 
GOWOONSESANG COSMETICS CO., LTD.