28778de2-a4ce-4cda-8e9a-5edfd6cd9204

SPL v2
SPL
SPL Set ID 28778de2-a4ce-4cda-8e9a-5edfd6cd9204
Route
topical
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
aminomethylpropanol carbomer homopolymer type a glycerin propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-19

Purpose

Antiseptic

Description

Ethyl alcohol 70% (v/v)


Medication Information

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

  • on children less than 2 months old.
  • on open skin wounds.

When using this product

  • keep out of eyes, In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin.
  • do not inhale or ingest.

Stop use and ask a doctor if

  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Do not store above 105°F.
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.
Inactive Ingredients

aminomethyl propanol, carbomer, homopolymer, glycerin, propylene glycol, purified water USPglycerin, hydrogen peroxide, purified water USP

Description

Ethyl alcohol 70% (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. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Ethyl alcohol 70% (v/v)

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

  • on children less than 2 months old.
  • on open skin wounds.

When using this product

  • keep out of eyes, In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin.
  • do not inhale or ingest.

Stop use and ask a doctor if

  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Do not store above 105°F.
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.
Inactive Ingredients (Inactive ingredients)

aminomethyl propanol, carbomer, homopolymer, glycerin, propylene glycol, purified water USPglycerin, hydrogen peroxide, purified water USP

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. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Ethyl alcohol 70% (v/v)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)