ECO FACE 9: Package Insert and Label Information

ECO FACE 9- allantoin shampoo
Eco Face Shop

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

Active ingredients: Allantoin 2.0%

INACTIVE INGREDIENT

Inactive ingredients: Water,Dendropanax Morbifera Extract,Disodium Laureth Sulfosuccinate,Coco-Btaine,Glycerin,Polyquaternium-10,Citrus Limon (Lemom) Fruit Oil,Rosmarinus Officinalis (Rosemary) Leaf Oil,Silk Amino Acid,Hydrolyzed Collagen,Hydrolyzed Elastin, ,Zanthoxy Sodium Hyaluronate lum Piperitum Fruit Extract,Citrus Grandis (Grapefruit) Seed Extract,Pulsatilla Koreana Extract,Centella Asiatica Extract,Perilla Ocymoides Leaf Extarct,Atractylodes Lancea Root Extract,Sciadopitys Verticallata Root Extract,Foeniculum Vulgare (Fennel) Fruit Extract,Cinnamomum Camphora (Camphor) Gum Extract,Tanacetum Cinerariifolium (Pyrethrum) Root Extract,Lespedeza Bicolor Bark Extract.

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only 1.If the following signs occur ,please stop using and rinse with water or consult a dermatologist .(red, swelling,itchy and during and after use) 2.Avoide contacting with eyes,if contact occurs,rinse eyes with water. 3.Avoid using on open wound or dermatitis. 4.Keep away from the reach of baby and children. 5.Keep away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep away from the reach of baby and children.

Uses

Uses: Intensive care of damaged hair.Prevention of demodex,Strengthen of hair root.Prevention of hair loss and protection of scalp.It’s good to use the shampoo after drying or perm hair ,also recommend use all skin types but especially for seborrheic dermatitis,dandruff, pruritus,etc.

Directions

Directions: Put a resonable amount of the shmpoo onto hair scalp and massage the shampoo into scalp ,and rinse the hair with warm water. Hair conditioner is not used!

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ECO FACE 9
allantoin shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71672-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 6.0 g in 300 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71672-010-02 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP (71672-010-01)
1 NDC:71672-010-01 300 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (71672-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/01/2017
Labeler — Eco Face Shop (694860266)
Registrant — Eco Face Shop (694860266)
Establishment
Name Address ID/FEI Operations
Eco Face Shop 694860266 manufacture (71672-010)

Revised: 09/2017 Eco Face Shop

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