hand sanitizer antiseptic gel

hand sanitizer antiseptic gel
SPL v2
SPL
SPL Set ID 87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc
Route
topical
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 g)
Inactive Ingredients
acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) aloe barbadensis leaf juice aminomethyl propanol denatonium benzoate glycerin propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-17

Purpose

Antiseptic handwash

Description

Ethyl Alcohol 62% v/v


Medication Information

Warnings

For external use only

Flammable, keep away from heat and flame

Uses

For hanwashing to help decrease bacteria on the skin. Recommended for repeated use.

Purpose

Antiseptic handwash

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6 years of age; use only under adult supervision
Description

Ethyl Alcohol 62% v/v

Section 51945-4

Section 60561-8
  • Store at 59° to 86°F (15-30°C)
Active Ingredients

Ethyl Alcohol 62% v/v

Inactive Ingrediends

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, denatonium benzoate, fragrance, glycerin, propylene glycol, tocopheryl acetate, water.

When Using This Product
  • do not use in the eyes
  • in case of contact, rinse eyes throughly with water
Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222


Structured Label Content

Warnings

For external use only

Flammable, keep away from heat and flame

Uses

For hanwashing to help decrease bacteria on the skin. Recommended for repeated use.

Purpose

Antiseptic handwash

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6 years of age; use only under adult supervision
Section 51945-4 (51945-4)

Section 60561-8 (60561-8)
  • Store at 59° to 86°F (15-30°C)
Active Ingredients

Ethyl Alcohol 62% v/v

Inactive Ingrediends (Inactive ingrediends)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, denatonium benzoate, fragrance, glycerin, propylene glycol, tocopheryl acetate, water.

When Using This Product (When using this product)
  • do not use in the eyes
  • in case of contact, rinse eyes throughly with water
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)