ac55bf20-47ee-49da-e053-2a95a90ac988

SPL v1
SPL
SPL Set ID ac55bf20-47ee-49da-e053-2a95a90ac988
Route
topical
Published
Effective Date 2020-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
maltodextrin aloe vera leaf water glycerin propylene glycol carbomer copolymer type a (allyl pentaerythritol crosslinked) fd&c yellow no. 5 trolamine .alpha.-tocopherol acetate fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-07

Purpose

Antiseptic

Description

Ethyl Alcohol 62%


Medication Information

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping.

.

Other Information

Do not store above 110 °F, May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C 10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, FD&C Yellow No. 5. FD&C Blue No.1

Description

Ethyl Alcohol 62%

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Children under 6 years of age should be supervised when using this product.

Section 50566-9

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

Section 50567-7

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

Section 51945-4

Warnings:

Not recommended for infants.

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping.

.

Other Information

Do not store above 110 °F, May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C 10-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, FD&C Yellow No. 5. FD&C Blue No.1

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Children under 6 years of age should be supervised when using this product.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Warnings:

Not recommended for infants.

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Active Ingredient

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

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