43116-006

43116-006
SPL v4
SPL
SPL Set ID aa4f59a5-0a55-df6d-e053-2995a90af8cb
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

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

As hand sanitizer to help reduce bacteria that can potentially cause disease(s) For use when soap and water are not available

Section 44425-7

Store between 59-86F(15-30.C). Do not leave or store in car. Avoid freezing and excessive heat above 104°F(40°C)

Section 50565-1

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

Section 50566-9

/

Section 50567-7

Keep out of eyes,ears, and mouth. In case of contact with eyes, rinse eyes thoroughly With water. Immediately discontinue use and contact your doctor if irritation or rash occurs, as these may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50570-1

DO NOT USE on open skin wounds. DO NOT USE on children less than 2 months of age. DO NOT USE if you are allergic to any ingredients

Section 55106-9

Ethyl Alcohol 75%

Warnings

For external user only Flammable Keep away from heat or flame

Directions

Apply enough product on hands to cover hands completely. Rub hands together until dry.

Supervise childreh under 6 years of age when using this product to avoid swallowing.

Inactive Ingredients

Water(Aqua),Non-woven

Package Label Principal Display Panel


Structured Label Content

Uses

As hand sanitizer to help reduce bacteria that can potentially cause disease(s) For use when soap and water are not available

Section 44425-7 (44425-7)

Store between 59-86F(15-30.C). Do not leave or store in car. Avoid freezing and excessive heat above 104°F(40°C)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

/

Section 50567-7 (50567-7)

Keep out of eyes,ears, and mouth. In case of contact with eyes, rinse eyes thoroughly With water. Immediately discontinue use and contact your doctor if irritation or rash occurs, as these may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50570-1 (50570-1)

DO NOT USE on open skin wounds. DO NOT USE on children less than 2 months of age. DO NOT USE if you are allergic to any ingredients

Section 55106-9 (55106-9)

Ethyl Alcohol 75%

Purpose

Antimicrobial

Warnings

For external user only Flammable Keep away from heat or flame

Directions

Apply enough product on hands to cover hands completely. Rub hands together until dry.

Supervise childreh under 6 years of age when using this product to avoid swallowing.

Inactive Ingredients (Inactive ingredients)

Water(Aqua),Non-woven

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)