SPL v1
SPL
SPL Set ID bc286dce-2ba4-4f1c-e053-2a95a90a2a6b
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.45 mL)
Inactive Ingredients
Macadamia Oil Glycerin Water Carbomer Interpolymer Type A (55000 Cps) Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-19

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

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • 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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Macadamia Ternifolia Nut Oil, Fragrance

Package Label Principal Display Panel

50 mL NDC: 80068-007-50

Distibuted by: Flex Technologies, Inc, 10432 Balls Ford Rd. Suite 300, Manassas, VA 20109, USA


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • 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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, Propylene Glycol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Macadamia Ternifolia Nut Oil, Fragrance

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

50 mL NDC: 80068-007-50

Distibuted by: Flex Technologies, Inc, 10432 Balls Ford Rd. Suite 300, Manassas, VA 20109, USA


Advanced Ingredient Data


Raw Label Data

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