Summer Dream Foam83584-424

Summer Dream Foam83584-424
SPL v1
SPL
SPL Set ID 2b835d26-b013-1d11-e063-6394a90ae41b
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
Edetate Disodium Glycerin Phenoxyethanol Peg-7 Glyceryl Cocoate Citric Acid Polysorbate 20 Cocamidopropyl Betaine Sodium Benzoate Aloe Vera Leaf Water Sodium Laureth Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

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



Chloroxylenol 0.23% v/v

Section 55105-1



Antiseptic

Package Label.principal Display Panel


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)



Chloroxylenol 0.23% v/v

Section 55105-1 (55105-1)



Antiseptic

Package Label.principal Display Panel (Package label.principal display panel)


Advanced Ingredient Data


Raw Label Data

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