47993-364

47993-364
SPL v2
SPL
SPL Set ID 512aabb7-266a-4873-a095-d8d32d2250be
Route
TOPICAL
Published
Effective Date 2024-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Trolamine Aloe Vera Leaf .alpha.-tocopherol Ferrosoferric Oxide Ferric Oxide Yellow D&c Red No. 30

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-28

Description

Active ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Flammable. Keep away from fire and flame.

Indications and Usage

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration

Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.

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

Description

Active ingredients Ethyl Alcohol 62%

Section 50565-1

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

Section 50566-9

Discontinue use if irritation or redness develops.

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 51727-6

Inactive Ingredients:

Water,Glycerin,Carbomer,Fragrance,Triethanolamine,Aloe Barbadensis Leaf Juice,Vitamin E,Iron Oxide(CI77499),Iron Oxide(CI 77492),D&C Red No.30.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 62%

Section 60561-8

Other information

Store Below 110℉(43℃)

May discolor certain fabrocs or surfaces


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.

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

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Flammable. Keep away from fire and flame.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Discontinue use if irritation or redness develops.

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 51727-6 (51727-6)

Inactive Ingredients:

Water,Glycerin,Carbomer,Fragrance,Triethanolamine,Aloe Barbadensis Leaf Juice,Vitamin E,Iron Oxide(CI77499),Iron Oxide(CI 77492),D&C Red No.30.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other information

Store Below 110℉(43℃)

May discolor certain fabrocs or surfaces


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)