SPL v1
SPL
SPL Set ID 501e720c-7114-4765-833f-7a1233421792
Route
TOPICAL
Published
Effective Date 2020-04-24
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%

Purpose

Sanitizer


Medication Information

Purpose

Sanitizer

Description

Ethyl Alcohol 70%

Uses
  • 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%

Inactive Ingredients

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide   

Package Label Principal Display Panel

label 60 mL


Structured Label Content

Uses
  • 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%

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide   

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

label 60 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)