a4b6d3a0-35e5-5861-e053-2a95a90a8ceb

SPL v2
SPL
SPL Set ID a4b6d3a0-35e5-5861-e053-2a95a90a8ceb
Route
topical
Published
Effective Date 2021-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.102 mL)
Inactive Ingredients
trolamine glycerin carbomer 980 water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-29

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only-hands. Flammable. Keep away from heat or flame. Not recommended for infants.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Wet hands thoroughly with product and allow to dry
  • Store in cool dry place
Inactive Ingredients

carbomer, sterile distilled water, triethanolamine.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use
  • To decrease bacteria on the skin
  • Recommended for repeated use
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 skin irritation develops.

Section 50567-7

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



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



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use
  • Children under 4 year of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

30 mL NDC: 77207-136-1


Structured Label Content

Warnings

For external use only-hands. Flammable. Keep away from heat or flame. Not recommended for infants.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Wet hands thoroughly with product and allow to dry
  • Store in cool dry place
Inactive Ingredients (Inactive ingredients)

carbomer, sterile distilled water, triethanolamine.

Use
  • To decrease bacteria on the skin
  • Recommended for repeated use
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 skin irritation develops.

Section 50567-7 (50567-7)

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



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



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use (Do not use)
  • Children under 4 year of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

30 mL NDC: 77207-136-1


Advanced Ingredient Data


Raw Label Data

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