PHYLLIS GOLDEN HAIR: Package Insert and Label Information

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.

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.

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PHYLLIS GOLDEN HAIR oatmeal shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52841-010
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 0.004 mL in 400 mL
Inactive Ingredients
Ingredient Name Strength
WATER
AMMONIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
GLYCINE
GOLD
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52841-010-01 400 mL in 1 CARTON None
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 Operations
UNOCOS CO., LTD. 557799050 manufacture

Revised: 01/2011 UNOCOS CO., LTD.

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