43116-031

43116-031
SPL v2
SPL
SPL Set ID 020f8bd6-21ac-0732-e063-6394a90a125e
Route
CUTANEOUS
Published
Effective Date 2023-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenoxyethanol (0.3 g)
Inactive Ingredients
Water Hydantoin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-08-04

Description

Phenoxyethanol 0.3%

Purpose

Cleaning


Medication Information

Purpose



Cleaning

Description

Phenoxyethanol 0.3%

Uses

CPAP WIPES to help to clean and reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Section 51945-4

Warnings

For external use only.

Directions



Wipe your CPAP Mask after each use and discard the wipe after cleaning. Let CPAP mask air dry. Keep cover closed in between uses to prevent drying. If irritation occurs discontinue use and seek medical advice. Store in a cool dry place.

Do Not Use

On children less than 2 months of age

On open skin wounds

Active Ingredient



Phenoxyethanol 0.3%

Other Information

-N/A

Inactive Ingredients

DMDMH, Water (Aqua)

When Using This Product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children



Kep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

CPAP WIPES to help to clean and reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Section 51945-4 (51945-4)

Purpose



Cleaning

Warnings

For external use only.

Directions



Wipe your CPAP Mask after each use and discard the wipe after cleaning. Let CPAP mask air dry. Keep cover closed in between uses to prevent drying. If irritation occurs discontinue use and seek medical advice. Store in a cool dry place.

Do Not Use (Do not use)

On children less than 2 months of age

On open skin wounds

Active Ingredient



Phenoxyethanol 0.3%

Other Information (Other information)

-N/A

Inactive Ingredients (Inactive ingredients)

DMDMH, Water (Aqua)

When Using This Product (When using this product)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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



Kep 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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