SPL v3
SPL
SPL Set ID f83069a8-2ff0-46c4-88ce-b0d6c3be40e8
Route
TOPICAL
Published
Effective Date 2020-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Sodium Hydroxide Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-17

Description

Ethyl Alcohol 75% v/v

Purpose

Sanitizer


Medication Information

Purpose

Sanitizer

Description

Ethyl Alcohol 75% v/v

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Section 50565-1

Keep out of reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immedietly.

Warnings

For external use only-hands. Use only as directed. Excessive use or prolonged exposure may cause irritation to skin. Discontinue use if rash, redness or itching appears. Flammable. Keep away from heat or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor. 
  • avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develops.

Directions

Put a thumb size amount in your palm and rub hands together briskly until dry.

Other information:

  • do not store in temperature over 118F.
  • children under the 6 years of age should be supervised while using this product.
  • may discolor certain fabrics.
Product Labels

Active Ingredient

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide, Aloe


Structured Label Content

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immedietly.

Purpose

Sanitizer

Warnings

For external use only-hands. Use only as directed. Excessive use or prolonged exposure may cause irritation to skin. Discontinue use if rash, redness or itching appears. Flammable. Keep away from heat or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor. 
  • avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develops.

Directions

Put a thumb size amount in your palm and rub hands together briskly until dry.

Other information:

  • do not store in temperature over 118F.
  • children under the 6 years of age should be supervised while using this product.
  • may discolor certain fabrics.
Product Labels (Product labels)

Active Ingredient

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide, Aloe


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)