ndc 63148-500, life is simple- alcohol free hand sanitizer

ndc 63148-500, life is simple- alcohol free hand sanitizer
SPL v3
SPL
SPL Set ID 0c5fad07-a91a-4d5f-8554-0d2f3a13ab13
Route
topical
Published
Effective Date 2020-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1 mg)
Inactive Ingredients
camellia sinensis leaf peg-40 hydrogenated castor oil fragrance clean orc0600327 polysorbate 20 ppg-26-buteth-26 aloe vera leaf dmdm hydantoin sodium hydroxide fd&c blue no. 1 fd&c yellow no. 5 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-06

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%


Medication Information

Warnings

For External use only

Uses

To help decrease bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • Pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.
  • Children under 6 years should be supervised when using this product.

Other Information
  • Store at room temperature

Inactive Ingredients

Water, Polysorbate 20, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140)

Description

Benzalkonium Chloride 0.1%

Do Not Use
  • on children less than 2 months of age.
  • on open wounds. 
Package Label

Active Ingredients

Benzalkonium Chloride 0.1%

Questions Or Comments ?

1-866-695-3030

When Using This Product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor

If irritation or redness develops and lasts more than 7 days.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Centre immedoately


Structured Label Content

Warnings

For External use only

Uses

To help decrease bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • Pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.
  • Children under 6 years should be supervised when using this product.

Other Information (Other information)
  • Store at room temperature

Inactive Ingredients

Water, Polysorbate 20, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140)

Do Not Use (Do not use)
  • on children less than 2 months of age.
  • on open wounds. 
Package Label

Active Ingredients

Benzalkonium Chloride 0.1%

Questions Or Comments ? (Questions or comments ?)

1-866-695-3030

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develops and lasts more than 7 days.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, get medical help or contact a Poison Control Centre immedoately


Advanced Ingredient Data


Raw Label Data

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