SPL v2
SPL
SPL Set ID bc99ad3c-e8bd-355d-e053-2995a90af783
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.02 mL)
Inactive Ingredients
.alpha.-tocopherol Trolamine Carbomer 940 Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

Recommended for repeated use.

For handwashing to decrease bacteria on the skin.

Section 43683-2

Indications and Usage: Change wordings

Directions: Change wordings

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

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.



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

Warnings

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

Directions
  • We hands thoroughly with product
  • Brisky rub hands together until dry
  • Supervise children under 6 years in the use of this product.
Do Not Use
  • in the eyes. In case of contact, rinse eyes thoroughly with water
Other Information
  • May discolor certain fabrics
  • Store at the normal temperature
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

Package Label Principal Display Panel

100 mL NDC: 81650-100- 01

250 mL NDC: 81650-100- 02

500 mL NDC: 81650-100- 03

1000 mL NDC: 81650-100- 04


Structured Label Content

Use

Recommended for repeated use.

For handwashing to decrease bacteria on the skin.

Section 43683-2 (43683-2)

Indications and Usage: Change wordings

Directions: Change wordings

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)

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.



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

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • We hands thoroughly with product
  • Brisky rub hands together until dry
  • Supervise children under 6 years in the use of this product.
Do Not Use (Do not use)
  • in the eyes. In case of contact, rinse eyes thoroughly with water
Other Information (Other information)
  • May discolor certain fabrics
  • Store at the normal temperature
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

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

100 mL NDC: 81650-100- 01

250 mL NDC: 81650-100- 02

500 mL NDC: 81650-100- 03

1000 mL NDC: 81650-100- 04


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)