77573-003

77573-003
SPL v2
SPL
SPL Set ID e5f88f94-a9eb-4db8-92d9-eb6a93ab0a93
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Trolamine Water Carbomer 940 Glycerol Formal Aloe .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-25

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Use

To reduce bacteria that potentially can cause disease

Recommended for repeated use

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 redness occurs. These may be signs of a serious condition

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do not use

In children less than 2 months of age

On open sin wounds

Section 51945-4

Warnings

For external use only -hands

Flammable. Keep away from heat and flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • For children under 6, use only under adult supervision
Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store between 15-30C (59 to 86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, aloe extract, triethanolamine, glycerol, carbomer, vitamin E, Fragrance


Structured Label Content

Use

To reduce bacteria that potentially can cause disease

Recommended for repeated use

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 redness occurs. These may be signs of a serious condition

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do not use

In children less than 2 months of age

On open sin wounds

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only -hands

Flammable. Keep away from heat and flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • For children under 6, use only under adult supervision
Active Ingredient

Ethyl Alcohol 70% v/v

Other Information (Other information)

Store between 15-30C (59 to 86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Water, aloe extract, triethanolamine, glycerol, carbomer, vitamin E, Fragrance


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)