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SPL v1
SPL
SPL Set ID bb3bb2af-b88b-41fc-893a-0b8ce4a69ed3
Route
TOPICAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Sodium Lauroamphoacetate Cocamidopropylamine Oxide Water Fd&c Blue No. 1 Cocamidopropyl Betaine Glycerin Olea Europaea Leaf Cetylpyridinium Chloride Citric Acid Monohydrate Disodium Hedta Benzophenone Methylchloroisothiazolinone Methylisothiazolinone D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-31

Description

Benzalkonium Chloride 0.13%


Medication Information

Description

Benzalkonium Chloride 0.13%

Use

Helps eliminate bacteria on hands

Section 51945-4

Section 55105-1

Purpose: 

Antibacterial

Warnings

For external use only

Directions

Apply onto wet hands. Lather and rinse thoroughly

Other Information

Store at room temperature

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride, Blue 1 (CI42090), Red 33 (CI17200)

When Using This Product

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop Use and Ask A Doctor

if redness and irrigation develop and last

Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Use

Helps eliminate bacteria on hands

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: 

Antibacterial

Warnings

For external use only

Directions

Apply onto wet hands. Lather and rinse thoroughly

Other Information (Other information)

Store at room temperature

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride, Blue 1 (CI42090), Red 33 (CI17200)

When Using This Product (When using this product)

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

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

if redness and irrigation develop and last

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

if swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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