Strengthwins ™ 

Strengthwins ™ 
SPL v2
SPL
SPL Set ID 5bf577e2-5e5b-497d-bf50-4dcd6662d632
Route
TOPICAL
Published
Effective Date 2020-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Aloe Vera Leaf Ethylhexylglycerin Glycerin Phenoxyethanol Polyaminopropyl Biguanide Propylene Glycol .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-01

Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.1%

Uses

• hand wipes to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5

​Apoly​™

ANTI-BACTERIAL WIPES

DISTRIBUTED BY

STRENGTHWINS L.L.C SANTA ANA, CA 92704

Made in China

• Naturally scented

• Antiseptic

• Soft, cloth like texture

• Effective way to keep your family hygienically clean and protected.

• Safe for cleaning or sanitizing skin

DIRECTIONS

Open the lid

Peel the foil seal to access the wipes

Pull out the central wipe

Thread the middle wipe through the opening of the lid

Re-place lid leaving the tissue through the top

Close lid to retain moisture

Lot. No:

Expiry: 

Section 50565-1

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

Section 51727-6

Inactive ingredients aloe vera (Aloe barbadensis) leaf extract, ethylhexylglycerin, glycerin, phenoxyethanol, polyaminopropyl biguanide, propylene glycol, vitamin E, water

Section 53413-1

Questions? +1-800-FDA-1088

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

• discard wipes in a trash receptacle after use. Do not flush

Drug Facts

Active Ingredient

Benzalkonium chloride 0.1%

Other Information

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°F)


Structured Label Content

Uses

• hand wipes to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5 (42229-5)

​Apoly​™

ANTI-BACTERIAL WIPES

DISTRIBUTED BY

STRENGTHWINS L.L.C SANTA ANA, CA 92704

Made in China

• Naturally scented

• Antiseptic

• Soft, cloth like texture

• Effective way to keep your family hygienically clean and protected.

• Safe for cleaning or sanitizing skin

DIRECTIONS

Open the lid

Peel the foil seal to access the wipes

Pull out the central wipe

Thread the middle wipe through the opening of the lid

Re-place lid leaving the tissue through the top

Close lid to retain moisture

Lot. No:

Expiry: 

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 51727-6 (51727-6)

Inactive ingredients aloe vera (Aloe barbadensis) leaf extract, ethylhexylglycerin, glycerin, phenoxyethanol, polyaminopropyl biguanide, propylene glycol, vitamin E, water

Section 53413-1 (53413-1)

Questions? +1-800-FDA-1088

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions

• wet hands thoroughly with product and allow to dry without wiping

• supervise children under 6 years of age when using this product to avoid swallowing

• discard wipes in a trash receptacle after use. Do not flush

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Other Information (Other information)

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°F)


Advanced Ingredient Data


Raw Label Data

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