SPL v1
SPL
SPL Set ID b00b0c3e-2a45-4c53-9222-037abdfe85dc
Route
TOPICAL
Published
Effective Date 2020-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

Ethyl Alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

To reduce 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

Section 50566-9

Stop use and ask a doctor if irritation and redness develop and condistion persists for more than 72 hours

Section 50567-7

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

Section 51945-4

Warnings

For external use only -hands

Flammable. Keep away from fire or flame

Directions
  • Wet hands thoroughly with product and rub until dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, glycerin, olive oil PEG-7 ester, acrylates /C10-30 alkyl acrylate cross polymer, triethanolamine, fragrance


Structured Label Content

Use

To reduce 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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop and condistion persists for more than 72 hours

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only -hands

Flammable. Keep away from fire or flame

Directions
  • Wet hands thoroughly with product and rub until dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Other Information (Other information)

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, olive oil PEG-7 ester, acrylates /C10-30 alkyl acrylate cross polymer, triethanolamine, fragrance


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)