San-e-pur Antiseptic Wipes

San-e-pur Antiseptic Wipes
SPL v2
SPL
SPL Set ID c2d2d8a1-4b2f-4718-b008-3adc0e9cc9b0
Route
TOPICAL
Published
Effective Date 2020-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Edetate Disodium Anhydrous Phenoxyethanol Polysorbate 20 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-20

Description

Active Ingredient Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses • wipes to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and Administration

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

Description

Active Ingredient Benzalkonium Chloride 0.13%

Section 42229-5

PROTECT CARE

San-E-Pur antiseptic wipes are safe for skin and are perfect for cleaning and reducing bacteria from hands.

Ideal for sanitizing and eliminating contaminates when soap and water is not available. Our alcohol free-based

formula effectively reduces bacteria as well as serves as an antiseptic agent

Helps In Reducing Bacteria Safe for Skin 

KILLS GERMS

ALCOHOL FREE

Wipe Size

(5.9" x 7.8")

(15 cm x 20 cm) 

DIRECTIONS FOR USE

Adults and children 2 years and over: Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

RECOMMENDED USE

  • Antibacterial (skin) cleanser.
  • Antiseptic (skin) cleanser.
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
  • For personal hand hygiene to help prevent the spread of bacteria.
  • Kills harmful bacteria/germs.



Store in a cool and dry place, away from direct sunlight.

Do not use if the inner seal is broken.

Distributed by:

ACOR FOODS-CSFTN LLC

1400 Veterans Memorial HWY SE

Suite 134#374

Mableton, GA 30126

www.san-e-pur.com

made in China

Section 44425-7

Other information  • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

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  Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water

Section 53413-1

Questions?

+1-901-212-1386

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13%

Packaging

Drug Facts


Structured Label Content

Indications and Usage (34067-9)

Uses • wipes to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

PROTECT CARE

San-E-Pur antiseptic wipes are safe for skin and are perfect for cleaning and reducing bacteria from hands.

Ideal for sanitizing and eliminating contaminates when soap and water is not available. Our alcohol free-based

formula effectively reduces bacteria as well as serves as an antiseptic agent

Helps In Reducing Bacteria Safe for Skin 

KILLS GERMS

ALCOHOL FREE

Wipe Size

(5.9" x 7.8")

(15 cm x 20 cm) 

DIRECTIONS FOR USE

Adults and children 2 years and over: Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

RECOMMENDED USE

  • Antibacterial (skin) cleanser.
  • Antiseptic (skin) cleanser.
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
  • For personal hand hygiene to help prevent the spread of bacteria.
  • Kills harmful bacteria/germs.



Store in a cool and dry place, away from direct sunlight.

Do not use if the inner seal is broken.

Distributed by:

ACOR FOODS-CSFTN LLC

1400 Veterans Memorial HWY SE

Suite 134#374

Mableton, GA 30126

www.san-e-pur.com

made in China

Section 44425-7 (44425-7)

Other information  • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

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  Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water

Section 53413-1 (53413-1)

Questions?

+1-901-212-1386

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13%

Packaging (packaging)

Drug Facts


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)