SPL v2
SPL
SPL Set ID b640fa53-80d6-4eb9-9994-790a96a166d4
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer, Unspecified Type Trolamine Aloe Vera Leaf Lemon Oil Orange Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

ALCOHOL 70% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ALCOHOL 70% v/v

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Flammable. Keep away from fire or flame

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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Stop use and ask a doctor if irritation or rash appears and lasts.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Children under 6 years of age should be supervised when using BIGGREEN

Active Ingredient

ALCOHOL 70% v/v

Other Information

• Store below 110°F(43°C)

• May discolor certain fabrics or surfaces

Inactive Ingredients

Purified Water, Glycerin, Carbomer, Triethanolamine, Aloe Extract, Allantoin, Lemon Oil, Orange Oil

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label: Natural Aroma Hand Sanitizer 250ml

Package Label: Natural Aroma Hand Sanitizer 500ml


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on the skin

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

For external use only. Flammable. Keep away from fire or flame

----------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

----------------------------------------------------------------------------

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

----------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Children under 6 years of age should be supervised when using BIGGREEN

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70% v/v

Other Information (Other information)

• Store below 110°F(43°C)

• May discolor certain fabrics or surfaces

Inactive Ingredients (INACTIVE INGREDIENTS)

Purified Water, Glycerin, Carbomer, Triethanolamine, Aloe Extract, Allantoin, Lemon Oil, Orange Oil

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.

Package Label: Natural Aroma Hand Sanitizer 250ml (Package Label: Natural Aroma Hand Sanitizer 250mL)

Package Label: Natural Aroma Hand Sanitizer 500ml (Package Label: Natural Aroma Hand Sanitizer 500mL)


Advanced Ingredient Data


Raw Label Data

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