SPL v2
SPL
SPL Set ID a7dfdefe-05ca-d2b8-e053-2a95a90ad4ef
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Butylene Glycol Trolamine Water Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

Hand sanitizinggel 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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

when using this product, do not use in or near eyes. Incase of contact, rinse eyes thoroughly with water. Stopuse and ask doctor if irritation or rash appears and lastsIf swallowed, get medical help or contact a Poison ControlCenter right away.

Warnings

WarningI This product is for external use and should not be takenorally

2. Use with caution for people with alcohol allergy

3. Keep out of reach of children

4. Highly flammable, keep away from fire and flame

5. Store in a cool, dry placeWhen using this produet, do not use in or near eyes. Incase of contact, rinse eyes thoroughly with water. Stopuse and ask doctor if irritation or rash appears and lastsIf swallowed, get medical help or contact a Poison ControlCenter right away

Directions

Direction: Wet and Rub where needed to be sanitizedwith the product thoroughly and allow to dry withoutwiping.

Rinse free.Children under 6 years of age should be supervised whenusing this product.

Do Not Use

/

Other Information
  • Other information:Store below 106F(41 C)May discolor certain fabric or surfaces
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

AQUA, 1.3 BUTYLENE GLYCOL, TROLAMINE, CARBOMER.

Package Label Principal Display Panel


Structured Label Content

Use

Hand sanitizinggel 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)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

when using this product, do not use in or near eyes. Incase of contact, rinse eyes thoroughly with water. Stopuse and ask doctor if irritation or rash appears and lastsIf swallowed, get medical help or contact a Poison ControlCenter right away.

Purpose

Antiseptic, Hand Sanitizer

Warnings

WarningI This product is for external use and should not be takenorally

2. Use with caution for people with alcohol allergy

3. Keep out of reach of children

4. Highly flammable, keep away from fire and flame

5. Store in a cool, dry placeWhen using this produet, do not use in or near eyes. Incase of contact, rinse eyes thoroughly with water. Stopuse and ask doctor if irritation or rash appears and lastsIf swallowed, get medical help or contact a Poison ControlCenter right away

Directions

Direction: Wet and Rub where needed to be sanitizedwith the product thoroughly and allow to dry withoutwiping.

Rinse free.Children under 6 years of age should be supervised whenusing this product.

Do Not Use (Do not use)

/

Other Information (Other information)
  • Other information:Store below 106F(41 C)May discolor certain fabric or surfaces
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

AQUA, 1.3 BUTYLENE GLYCOL, TROLAMINE, CARBOMER.

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


Advanced Ingredient Data


Raw Label Data

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