Fragrance Free Foam 83584-224

Fragrance Free Foam 83584-224
SPL v1
SPL
SPL Set ID 2b839af1-b387-e782-e063-6394a90ab528
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.23 g)
Inactive Ingredients
Sodium Laureth Sulfate Cocamidopropyl Betaine Phenoxyethanol Sodium Benzoate Aloe Vera Leaf Polysorbate 20 Glycerin Water Peg-7 Glyceryl Cocoate Edetate Disodium Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Chloroxylenol 0.23% v/v


Medication Information

Warnings and Precautions



For external use only.

Indications and Usage



For hand-washing to decrease bacteria on the skin.

Dosage and Administration



Wet hands and forearms.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 1 minute and rinse.

Description

Chloroxylenol 0.23% v/v

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 do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

Section 51727-6



Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Aloe Barbadensis Extract, Polysorbate 20, Peg-7 Glyceryl

Cocoate, Glycerin, Phenoxyethanol, Sodium Benzoate, Disodium Edta, Citric Acid.

Section 51945-4

Section 55105-1



Antiseptic

Section 55106-9



Chloroxylenol 0.23% v/v


Structured Label Content

Indications and Usage (34067-9)



For hand-washing to decrease bacteria on the skin.

Dosage and Administration (34068-7)



Wet hands and forearms.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 1 minute and rinse.

Warnings and Precautions (34071-1)



For external use only.

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 do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

Section 51727-6 (51727-6)



Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Aloe Barbadensis Extract, Polysorbate 20, Peg-7 Glyceryl

Cocoate, Glycerin, Phenoxyethanol, Sodium Benzoate, Disodium Edta, Citric Acid.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Antiseptic

Section 55106-9 (55106-9)



Chloroxylenol 0.23% v/v


Advanced Ingredient Data


Raw Label Data

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