Label: PHYLLIS GOLDEN HAIR ESSENCE- oatmeal solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52841-020-01 - Packager: UNOCOS 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 21, 2011
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
WARNINGS:
Use of the products should be discontinued if the following adverse reactions occur. As continued use may make symptoms worse, it is advisable to consult a dermatologist, Redness, swelling, itching, and sensitivity.
Redness, swelling, itching, sensitivity, and etc., caused by direct sunlight.
Do not use the products on sun burnt, wounded, eczema or dermatitis-affected regions.
If the product gets into your eyes, rinse your eyes with clean water.
Caution rinse thoroughly. Can cause loss of hair or discoloration.
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHYLLIS GOLDEN HAIR ESSENCE
oatmeal solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52841-020 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.0008 mL in 80 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MUNG BEAN (UNII: 1LIB31N73G) GOLD (UNII: 79Y1949PYO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52841-020-01 80 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/01/2010 Labeler - UNOCOS CO., LTD. (557799050) Registrant - UNOCOS CO., LTD. (557799050) Establishment Name Address ID/FEI Business Operations UNOCOS CO., LTD. 557799050 manufacture