SPL v1
SPL
SPL Set ID a3c8fcc1-df59-6dd0-e053-2995a90a5ea3
Route
TOPICAL
Published
Effective Date 2020-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.5 g)
Inactive Ingredients
Methyl Benzoate Glycerin Carbomer 934 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-21

Description

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria on skin

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

Warnings

Flammable. Keep away from fire or flame For external use only.

Directions
  • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry
  • Children under 6 years of age should be supervised when using this product
Do Not Use

Other Information

Store below 106 F(41 C)May discolor certain fabrics or surfaces

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

Aqua(Purified water),Glycerin,Carbomer,Parfum

When Using This Product

When using this product, Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask doctor if irritation or rash appears and lasts

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on skin

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)

Purpose

Antimicrobial

Warnings

Flammable. Keep away from fire or flame For external use only.

Directions
  • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry
  • Children under 6 years of age should be supervised when using this product
Do Not Use (Do not use)

Other Information (Other information)

Store below 106 F(41 C)May discolor certain fabrics or surfaces

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Aqua(Purified water),Glycerin,Carbomer,Parfum

When Using This Product (When using this product)

When using this product, Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask doctor if irritation or rash appears and lasts

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)