SPL v1
SPL
SPL Set ID cc8a2ffb-ef43-41f0-a503-0596577644c9
Route
TOPICAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Sodium Hydroxide

Identifiers & Packaging

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

Description

Ethyl Alcohol 70% v/v

Purpose

Sanitizer


Medication Information

Purpose

Sanitizer

Description

Ethyl Alcohol 70% v/v

Use
  • to decrease bacterias on the skin that could cause diseases.
  • 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.
Active Ingredient

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide

Package Label Principal Display Panel

Label 1

Label 2


Structured Label Content

Use
  • to decrease bacterias on the skin that could cause diseases.
  • 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.
Active Ingredient

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide

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

Label 1

Label 2


Advanced Ingredient Data


Raw Label Data

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