47993-310

47993-310
SPL v2
SPL
SPL Set ID a132702e-395d-451e-aa90-9457c8b49f66
Route
TOPICAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Carbomer 940 Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-31

Description

Active ingredients Ethyl alcohol 70% V/V


Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration

Directions:

Squeeze small amount in your palm and briskly rub hands together, and allow to air dry. For children under 6, use with adult supervision. Not recommended for infants.

Description

Active ingredients Ethyl alcohol 70% V/V

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask doctor if irritation or redness develops.

Section 50567-7

Keep away from eyes. Do not inhale or ingest.

Section 51727-6

Inactive Ingredients:

Water,Glycerol,Aloe barbadensis leaf juice,Carbomer,Triethanolamine

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl alcohol 70% V/V

Section 60561-8

Other information:

Store below 110℉(43℃).May discolor certain fabrics or surface.


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

Squeeze small amount in your palm and briskly rub hands together, and allow to air dry. For children under 6, use with adult supervision. Not recommended for infants.

Warnings and Precautions (34071-1)

Warnings:

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation or redness develops.

Section 50567-7 (50567-7)

Keep away from eyes. Do not inhale or ingest.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Glycerol,Aloe barbadensis leaf juice,Carbomer,Triethanolamine

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 110℉(43℃).May discolor certain fabrics or surface.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)