SPL v5
SPL
SPL Set ID acd38a33-f982-a3bb-e053-2a95a90ad94e
Route
TOPICAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 g)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-14

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

For hands sanitizing

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 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.

Warnings

Flammable. Keep away from heat or flame.

Directions
  • Open the package bag, take out the wipes and wipe throughly the hands to be sanitized.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store in cool and dry environment, keep sealed below 43C(110F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, purified water.

Package Label Principal Display Panel

10 WIPES in 1 BAG NDC: 80001-882-01


Structured Label Content

Use

For hands sanitizing

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 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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

Flammable. Keep away from heat or flame.

Directions
  • Open the package bag, take out the wipes and wipe throughly the hands to be sanitized.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store in cool and dry environment, keep sealed below 43C(110F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, purified water.

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

10 WIPES in 1 BAG NDC: 80001-882-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)