SPL v1
SPL
SPL Set ID be507751-ba1b-4ff2-e053-2995a90a7176
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (2 mg)
Inactive Ingredients
Glycerin Fragrance Floral Orc0902236 Water Chamomile Flower Oil Hydroxyethyl Cellulose, Unspecified Panthenol Tetrasodium Glutamate Diacetate Aloe Vera Leaf Birch Triterpenes

Identifiers & Packaging

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

Description

Benzalkonium Chloride, .2%. Purpose: Antiseptic

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride, .2%. 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.

Directions

Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. 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
Active Ingredient

Benzalkonium Chloride, .2%. Purpose: Antiseptic

Other Information
  • Store between 41-80F (5-27C).
  • Avoid freezing and excessive heat above 104F (40C).
Inactive Ingredients

Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract

Package Label Principal Display Panel

4L NDC: 78522-101-01


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

Warnings

For external use only.

Directions

Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. 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
Active Ingredient

Benzalkonium Chloride, .2%. Purpose: Antiseptic

Other Information (Other information)
  • Store between 41-80F (5-27C).
  • Avoid freezing and excessive heat above 104F (40C).
Inactive Ingredients (Inactive ingredients)

Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract

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

4L NDC: 78522-101-01


Advanced Ingredient Data


Raw Label Data

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