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

Description

Ethyl Alcohol 62% v/v

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Ethyl Alcohol 62% v/v

Uses

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

Section 51945-4

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

For external use only

Flammable, keep away from heat and flame

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

Uses

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

Section 51945-4 (51945-4)

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

Antiseptic handwash

Warnings

For external use only

Flammable, keep away from heat and flame

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

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