43116-047

43116-047
SPL v1
SPL
SPL Set ID 43d6041f-18d1-b0e3-e063-6294a90a7c79
Route
TOPICAL
Published
Effective Date 2025-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polihexanide (0.04 U) Benzalkonium (0.05 U)
Inactive Ingredients
Fragrance Green Floral Orc2000883 Citrus Limon (lemon) Peel Oil Jasminum Sambac (jasmine) Flower Oil Citric Acid Viola Odorata Oil Sodium Citrate Aqua Glycerin Propylene Glycol Chamomile Aloe Vera Leaf Camellia Sinensis Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-18

Description

Benzalkonium Chloride 0.05%. Poly (hexamethylenebiguanide) hydrochloride 0.04%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.05%. Poly (hexamethylenebiguanide) hydrochloride 0.04%

Use

Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

●For external use only.

●Disposable wipes, one-time use only.

Directions

●Tear open the single packet.

●Gently wipe thoroughly across your forehead, face, neck, and body.

●Do not Flush. Discard after use. No rinsing needed.

●Children under 6 years of age should be surpervised when using this product.

Do Not Use

Do not use if you are allergic to any of the ingredients, not suitable for the skin injuries.

When Using

When using this product, please do not use in or near the eyes.

In case of uncomfortable contact, rinse thoroughly with water.

Active Ingredient

Benzalkonium Chloride 0.05%.

Poly (hexamethylenebiguanide) hydrochloride 0.04%

Other Information

● Store below 77°F.(25"C)

● Store in a cool, dry and airy place.

● Validity period for 2 years.

Inactive Ingredients

Aqua, Glycerin, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract,

Aloe Vera Extract, Citric Acid, Sodium Citrate, Fragrance, Citrus Limon (Lemon) Peel Oil,

Camellia Sinensis Leaf Oil, Jasminum Sambac (Jasmine) Flower Oil, Violet Leaf Absolute.

Principal Display Panel

Keep Oot of Reach of Children

To avoid the risk of chocking and suffocation, keep wipes and plastic bag away from babies, children and pets.


Structured Label Content

Use

Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic

Purpose

Antibacterial

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

●For external use only.

●Disposable wipes, one-time use only.

Directions

●Tear open the single packet.

●Gently wipe thoroughly across your forehead, face, neck, and body.

●Do not Flush. Discard after use. No rinsing needed.

●Children under 6 years of age should be surpervised when using this product.

Do Not Use (Do not use)

Do not use if you are allergic to any of the ingredients, not suitable for the skin injuries.

When Using

When using this product, please do not use in or near the eyes.

In case of uncomfortable contact, rinse thoroughly with water.

Active Ingredient

Benzalkonium Chloride 0.05%.

Poly (hexamethylenebiguanide) hydrochloride 0.04%

Other Information (Other information)

● Store below 77°F.(25"C)

● Store in a cool, dry and airy place.

● Validity period for 2 years.

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract,

Aloe Vera Extract, Citric Acid, Sodium Citrate, Fragrance, Citrus Limon (Lemon) Peel Oil,

Camellia Sinensis Leaf Oil, Jasminum Sambac (Jasmine) Flower Oil, Violet Leaf Absolute.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

To avoid the risk of chocking and suffocation, keep wipes and plastic bag away from babies, children and pets.


Advanced Ingredient Data


Raw Label Data

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