SPL v1
SPL
SPL Set ID 0c73f4f5-2b1d-84ae-e063-6394a90a5d7b
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-14

Description

Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Uses
  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • for use when soap and water are not available
Label

Warnings

Flammable, keep away from fire/ flame

For external use only

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product.
Do Not Use
  • in the eyes
  • on children less than 2 years of age
  • on open skin wounds
When Using

When using this product keep out of eyes, ears, and mouth, In case of contact, rinse thoroughly with water.

Active Ingredient

Alcohol 70% v/v

Other Information
  • store between 15-30ºC (59-86ºF)
  • avoid freezing and excessive heat above 40ºC(104ºF)
Inactive Ingredients

WATER, CARBOMER, GLYCERIN, PROPYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE, ALOE(ALOE BARBADENSIS)LEAF JUICE, TOCOPHERYL ACETATE

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

if swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • Hand sanitizer to help reduce bacteria that potentially can cause disease
  • for use when soap and water are not available
Label (label)

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/ flame

For external use only

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product.
Do Not Use (Do not use)
  • in the eyes
  • on children less than 2 years of age
  • on open skin wounds
When Using (When using)

When using this product keep out of eyes, ears, and mouth, In case of contact, rinse thoroughly with water.

Active Ingredient (Active ingredient)

Alcohol 70% v/v

Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • avoid freezing and excessive heat above 40ºC(104ºF)
Inactive Ingredients (inactive ingredients)

WATER, CARBOMER, GLYCERIN, PROPYLENE GLYCOL, AMINOMETHYL PROPANOL, FRAGRANCE, ALOE(ALOE BARBADENSIS)LEAF JUICE, TOCOPHERYL ACETATE

Stop Use and Ask A Doctor If (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)