SPL v1
SPL
SPL Set ID aee64772-9f26-6a2f-e053-2a95a90a8e95
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
Carbomer Homopolymer, Unspecified Type Propylene Glycol Alpha-tocopherol Acetate Glycerin Water Trolamine Aloe Vera Leaf

Identifiers & Packaging

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

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
  • 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

000 mL NDC: 00000-000-00


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)
  • 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)

000 mL NDC: 00000-000-00


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)