43116-046

43116-046
SPL v1
SPL
SPL Set ID 3f5bbbc1-fdac-372e-e063-6394a90a5517
Route
TOPICAL
Published
Effective Date 2025-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polihexanide (0.15 U)
Inactive Ingredients
Aqua Propylene Glycol 1,2-hexanediol Polysorbate 20 Tussilago Farfara Centella Asiatica Triterpenoids

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-22

Description

Polihexanide Hydrochloride 0.1 5%(W/W)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Polihexanide Hydrochloride 0.1 5%(W/W)

Use

For underarm, privates, and beyond cleansing to help reduce odor and rfesh

skin. For use when showering or changing clothes is not available.

Stop Use

Stop use amitation or rash oC Thee maybe signs ofa serious condion

Warnings

●Keep away from fire or flame, heat and spark.

●For external use only.

Directions

1.Open the resealable label.

2.Pull out one deodorant wipe.

3.Wipe on body as needed to remove sweat and dirt.

4.Reseal pack when finished.

Do Not Use

On mucous membranes or broken skin.

When Using

●When using, discontinue if redness occurs (test on a small area first).

Active Ingredient

Polihexanide Hydrochloride 0.1 5%(W/W)

Other Information

●Store between 15-30C(59-86F).

●Avoid freezing and excessive heat above 40C(104F).

Inactive Ingredients

Aqua, Propylene Glycol, 1,2-Hexanediol,

Polysorbate 20, Tussilago Farfara Extract,

Centella Asiatica Extract

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children. nn swallol Control Center right away.Swa lowed, get medical help or contact a Poison


Structured Label Content

Use

For underarm, privates, and beyond cleansing to help reduce odor and rfesh

skin. For use when showering or changing clothes is not available.

Purpose

Antiseptic

Stop Use

Stop use amitation or rash oC Thee maybe signs ofa serious condion

Warnings

●Keep away from fire or flame, heat and spark.

●For external use only.

Directions

1.Open the resealable label.

2.Pull out one deodorant wipe.

3.Wipe on body as needed to remove sweat and dirt.

4.Reseal pack when finished.

Do Not Use (Do not use)

On mucous membranes or broken skin.

When Using

●When using, discontinue if redness occurs (test on a small area first).

Active Ingredient

Polihexanide Hydrochloride 0.1 5%(W/W)

Other Information (Other information)

●Store between 15-30C(59-86F).

●Avoid freezing and excessive heat above 40C(104F).

Inactive Ingredients (Inactive ingredients)

Aqua, Propylene Glycol, 1,2-Hexanediol,

Polysorbate 20, Tussilago Farfara Extract,

Centella Asiatica Extract

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children. nn swallol Control Center right away.Swa lowed, get medical help or contact a Poison


Advanced Ingredient Data


Raw Label Data

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