activex antibacterial hand wash

activex antibacterial hand wash
SPL v1
SPL
SPL Set ID b295f945-9043-b131-e053-2995a90ad5f6
Route
topical
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water glycerin peg-4 rapeseedamide cocamidopropylamine oxide lauryl glucoside cetrimonium chloride peg-120 methyl glucose dioleate cocamine oxide styrene/acrylamide copolymer (500000 mw) lauramine oxide lauramidopropylamine oxide malic acid sodium benzoate myristamidopropylamine oxide sodium salicylate phenoxyethanol sodium chloride edetate sodium sodium pyrrolidone carboxylate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-01

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only

Purpose

Antiseptic

Directions

- Wet hands and forearms.

- Apply 5mL or palmful to hands and forearms.

- Scrub thoroughly for 30 to 60 seconds.

- Rinse and Repeat.

Other Information

- Store in dry and cool place in the original packaging.

- Keep from light including direct sunlight.

Inactive Ingredients

Water, glycerin, PEG-4 rapeseedamide, cocamidopropylamine oxide, lauryl glucoside, cetrimonium chloride, PEG-120 methyl glucose dioleate, cocamine oxide, styrene/acrylamide copolymer, lauramine oxide, lauramidopropylamine oxide, malic acid, fragrance, sodium benzoate, myristamidopropylamine oxide, sodium salicylate, phenoxyethanol, sodium chloride, tetrasodium EDTA, sodium PCA.

Description

Benzalkonium Chloride 0.13%

Use

For hand washing to decrease bacteria on the skin

Do Not Use

in the eyes

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Package Labeling:

Questions Or Comments

1 (224) - 408-0663

Stop Use and Ask A Doctor If

- Irritation and redness develop

- Condition persists for more than 72 hours

Keep Out of Reach of Children.

- If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Purpose

Antiseptic

Directions

- Wet hands and forearms.

- Apply 5mL or palmful to hands and forearms.

- Scrub thoroughly for 30 to 60 seconds.

- Rinse and Repeat.

Other Information (Other information)

- Store in dry and cool place in the original packaging.

- Keep from light including direct sunlight.

Inactive Ingredients (Inactive ingredients)

Water, glycerin, PEG-4 rapeseedamide, cocamidopropylamine oxide, lauryl glucoside, cetrimonium chloride, PEG-120 methyl glucose dioleate, cocamine oxide, styrene/acrylamide copolymer, lauramine oxide, lauramidopropylamine oxide, malic acid, fragrance, sodium benzoate, myristamidopropylamine oxide, sodium salicylate, phenoxyethanol, sodium chloride, tetrasodium EDTA, sodium PCA.

Use

For hand washing to decrease bacteria on the skin

Do Not Use (Do not use)

in the eyes

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Package Labeling:

Questions Or Comments (Questions or comments)

1 (224) - 408-0663

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

- Irritation and redness develop

- Condition persists for more than 72 hours

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

- If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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