Label: FOUR SEASON ESSENCE- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61616-020-01 - Packager: OneLineSun Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 27, 2014
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Water, Panax Ginseng Root Extract, Thuja Occidentalis Leaf Extract, Morus Alba Bark Extract, Chrysanthemum Zawadskii Extract, Lycium Chinense Fruit Extract, Acorus Gramineus Root/Stem Extract, Xanthium Strumarium Fruit Extract, Glycyrrhiza Glabra, (Licorice) Root Extract, Mentha Arvensis Extract, Alcohol, Propylene Glycol, Dimethiconol, Menthol, Panthenol, Allantoin, Methylparaben, Glycyrrhiza Inflata Root Extract, Acorus calamus Root Extract, Camellia Sinensis Leat Extract, Disodium EDTA, Trithanolamine - PURPOSE
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WARNINGS
1. You can use the cosmetics, if there is an abnormality, such as the following, it is necessary to stop using, because it worsen the symptoms.
If you continue to use, that I talk to dermatologists.
If there is abnormal red spots, swelling, itching, and irritation to 1) use.
When there is an abnormality, such as described above by direct sunlight 2) the application site.
2. That you do not use the site to include a wound, the part with the abnormality of dermatitis and eczema.
3. When it got into eyes, be washed away immediately. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOUR SEASON ESSENCE
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61616-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic acid 2.16 mg in 120 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61616-020-01 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/01/2013 Labeler - OneLineSun Co., Ltd. (689003976) Registrant - OneLineSun Co., Ltd. (689003976) Establishment Name Address ID/FEI Business Operations OneLineSun Co., Ltd. 689003976 manufacture(61616-020)