47993-287

47993-287
SPL v2
SPL
SPL Set ID c99570cb-e2d3-4391-84c3-b46d7f838fe6
Route
TOPICAL
Published
Effective Date 2020-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Propanediol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-23

Description

Active ingredients Ethyl Alcohol 70% V/V


Medication Information

Warnings and Precautions

Warnings:

For external use only. Avoid contact with broken skin. Do not inhale or ingest.

Flammable. Keep away from fire or flame.

Indications and Usage

Uses:

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and Administration

Directions:

Place enough product in your palm. Rub hands vigorously until dry. Children under 6 years of age should be supervised when using this product.

Description

Active ingredients Ethyl Alcohol 70% V/V

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

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

Section 50567-7

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Inactive Ingredients:

Water,Glycerol,Propanediol,Aloe Barbadensis Leaf Extract,Fragrance.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 70% V/V

Section 60561-8

Other information:

Store below 106℉(41℃). May discolor certain fabrics or surfaces.


Structured Label Content

Indications and Usage (34067-9)

Uses:

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Place enough product in your palm. Rub hands vigorously 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. Avoid contact with broken skin. Do not inhale or ingest.

Flammable. Keep away from fire or 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)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Glycerol,Propanediol,Aloe Barbadensis Leaf Extract,Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 70% V/V

Section 60561-8 (60561-8)

Other information:

Store below 106℉(41℃). May discolor certain fabrics or surfaces.


Advanced Ingredient Data


Raw Label Data

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