SPL v1
SPL
SPL Set ID aed1e0de-a386-55e2-e053-2995a90a77fb
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Alpha-tocopherol Acetate Aloe Vera Leaf Propylene Glycol Glycerin Water Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-08

Description

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v.

Use
  • for handwashing to decrease bacteria on the skin
  • 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 persist for more than 72 hours.

Warnings

For external use only. Flammable, keep away from heat and flame

Directions
  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product
Do Not Use

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Other Information
  • store at room temperature
  • may discolor certain fabrics
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

Package Label Principal Display Panel


Structured Label Content

Use
  • for handwashing to decrease bacteria on the skin
  • 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 persist for more than 72 hours.

Purpose

Antimicrobial

Warnings

For external use only. Flammable, keep away from heat and flame

Directions
  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product
Do Not Use (Do not use)

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Other Information (Other information)
  • store at room temperature
  • may discolor certain fabrics
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)