SPL v4
SPL
SPL Set ID a3002a17-56d9-7ded-e053-2995a90a85eb
Route
TOPICAL
Published
Effective Date 2020-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Glycerin Fragrance Lavender & Chia F-153480

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-31

Description

Ethyl Alcohol 75%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75%

Uses

● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.

Stop:

Stop use and ask a doctor if ● Irritation and redness develops. ● Condition persists for more than 72 hours.

Section 51945-4

NDC

Warnings

Flammable. Keep away from fire or flame, For external use only.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 doctor if irritation or rash appears and lasts,Keep out of reach for children if swallowed,get medical help of contact a Poison Control Center right away.

Directions

Directions ● Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry. ● For children under 6, use only under adult supervision. ● Not recommended for infants.

Do Not Use:

Stop use and ask a doctor if ● Irritation and redness develops. ● Condition persists for more than 72 hours.

Childeren Safety

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

Active Ingredient

Ethyl Alcohol 75%

Other Information

Store below 110°(43°C)

May discolor certain fabrics or surfaces

Inactive Ingredients

Inactive ingredients Water, Glycerin, Aloe vera, Carbomer, Polyacrylate crosspolymer, Fragrance

When Using This Product:

● Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. ● Avoid contact with broken skin. ● Do not inhale or ingest.


Structured Label Content

Uses

● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.

Stop:

Stop use and ask a doctor if ● Irritation and redness develops. ● Condition persists for more than 72 hours.

Section 51945-4 (51945-4)

NDC

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fire or flame, For external use only.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 doctor if irritation or rash appears and lasts,Keep out of reach for children if swallowed,get medical help of contact a Poison Control Center right away.

Directions

Directions ● Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry. ● For children under 6, use only under adult supervision. ● Not recommended for infants.

Do Not Use:

Stop use and ask a doctor if ● Irritation and redness develops. ● Condition persists for more than 72 hours.

Childeren Safety

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

Active Ingredient

Ethyl Alcohol 75%

Other Information (Other information)

Store below 110°(43°C)

May discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Inactive ingredients Water, Glycerin, Aloe vera, Carbomer, Polyacrylate crosspolymer, Fragrance

When Using This Product: (When using this product:)

● Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. ● Avoid contact with broken skin. ● Do not inhale or ingest.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)