f2f03954-f47c-43f7-be63-376959b2059e

SPL v2
SPL
SPL Set ID f2f03954-f47c-43f7-be63-376959b2059e
Route
topical
Published
Effective Date 2020-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water glycerin aloe vera leaf carbomer homopolymer, unspecified type .alpha.-tocopherol acetate trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-26

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.


Medication Information

Warnings
  • For external use only
  • Flammable. Keep away from fire or flame.
  • Do not apply around eyes. Do not use in ears & mouth.
  • When using this product avoid contact with eyes.
  • In case of contact flush eyes with water.
  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Uses
  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repealed use.
Purpose

Antiseptic

Directions
  • Pump as needed into your palms and thoroughly spread on both hand.
  • Rub into skin until dry.
Other Information
  • Store at 20oC (88-77oF).
  • May discolor fabrics.
Inactive Ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Description

Ethyl Alcohol 75% v/v.

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Active Ingredient

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel

60 mL

100 mL

237 mL

500 mL


Structured Label Content

Warnings
  • For external use only
  • Flammable. Keep away from fire or flame.
  • Do not apply around eyes. Do not use in ears & mouth.
  • When using this product avoid contact with eyes.
  • In case of contact flush eyes with water.
  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Uses
  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repealed use.
Purpose

Antiseptic

Directions
  • Pump as needed into your palms and thoroughly spread on both hand.
  • Rub into skin until dry.
Other Information (Other information)
  • Store at 20oC (88-77oF).
  • May discolor fabrics.
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Active Ingredient

Ethyl Alcohol 75% v/v.

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

60 mL

100 mL

237 mL

500 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)