PHYLLIS GOLDEN HAIR- oatmeal shampoo 
UNOCOS 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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Drug Facts

Active Ingredient: OATMEAL

Inactive Ingredients:

WATER, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, PEG-7 GLYCERYL COCOATE, GLYCINE, SOJA (SOYBEAN) SEED EXTRACT, DECYL SODIUM CHLORIDE,
POLYQUATERNIUM-10, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, BAMBUSA ARUNDINACEA STEM EXTRACT,
PHASEOLUS RADIATUS SEED EXTRACT, LAMINARIA DIGITATA EXTRACT, GOLD, CITRIC ACID, BENZOPHENONE-5, DISODIUM EDTA, METHYLISOTHIAZOLINONE,
METHYLCHLOROISOTHIAZOLINONE, FRAGRANCE

Purpose:

It appears to protect from harmful ultraviolet rays as well as preventing oxidation.
Alleviates skin trouble from sensitive scalp while making glossy healthy hair.

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, and sensitivity caused by direct sunlight.
Do not use the products on sun burnt areas, wounded, eczema or dermatitis-affected regions.
If the product gets into your eyes, rinse your eyes with clean water.
Caution rinse thoroughly. If not, may cause loss of hair or discoloration

Keep out of reach of children:

Replace the caps after use.

Keep away from babies and children.

How to Use:

Apply to wet or damp hair with soft massage and rinse thoroughly.

Dosage and administration:

Apply to wet or damp hair with soft massage and rinse thoroughly.

Image of carton

PHYLLIS GOLDEN  HAIR
oatmeal shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52841-010
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.004 mL  in 400 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCINE (UNII: TE7660XO1C)  
GOLD (UNII: 79Y1949PYO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52841-010-01400 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2010
Labeler - UNOCOS CO., LTD. (557799050)
Registrant - UNOCOS CO., LTD. (557799050)
Establishment
NameAddressID/FEIBusiness Operations
UNOCOS CO., LTD.557799050manufacture

Revised: 1/2011
Document Id: 71aa7a87-ca1f-4b24-9813-921176f5a9a3
Set id: 513b3ef5-4321-47ed-91e3-b9a8518afb65
Version: 3
Effective Time: 20110121
 
UNOCOS CO., LTD.