Hi Hand Clean: Package Insert and Label Information

HI HAND CLEAN- hypochlorous acid liquid
Eco Face Shop

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Hypochlorous Acid 0.003%

INACTIVE INGREDIENTS

Allantoin, Aloe Barbadensis Leaf powder, Butylene Glycol, Carbomer, Citrus Limon(Lemon) Peel Oil/ Limonene, Citral, Glycerin, L-Arginine, Melaleuca Alternifolia(Tea Tree)Leaf Extract, Menthol, Niacinamide, Water, 1,2-Hexanediol

PURPOSE

Antiseptic and skin protection

WARNINGS

For external use only.
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Do not use

• in childre n less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• instant hand antiseptic to decrease bacteria on the skin

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
• Supervise children in the use of this product.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Avoid UV rays
• Notice by fair trade commission in case of any abnormality in this product we •Manufacturing date and period of use : three years from date of manufacture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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HI HAND CLEAN
hypochlorous acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71672-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPOCHLOROUS ACID (HYPOCHLOROUS ACID) HYPOCHLOROUS ACID 0.015 g in 500 mL
Inactive Ingredients
Ingredient Name Strength
Allantoin
ALOE VERA LEAF
Butylene Glycol
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Glycerin
Menthol
Niacinamide
Water
1,2-Hexanediol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71672-030-01 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2020
Labeler — Eco Face Shop (694860266)
Registrant — Eco Face Shop (694860266)
Establishment
Name Address ID/FEI Operations
Eco Face Shop 694860266 manufacture (71672-030)

Revised: 09/2020 Eco Face Shop

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