OTC Medication Information: Abutol Sanitizing Lemon and Mint

ABUTOL SANITIZING LEMON AND MINT- benzalkonium chloride spray
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

• Hand sanitizer to decrease bacteria on the skin
• Recommended for repeated use
• For use when soap and water are not available

Warnings

For external use only. Protect from the sunlight.

Do not use
• on children less than 2 months of age
• on open skin wounds

When using this product • Avoid use on/or around eyes, ears, mouth, broken/ irritated skin or large areas of body. In case of a contact with eyes, rinse thoroughly with water several minutes. do not inhale or ingest

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

Directions

• Hold upright at 6-7 inches away from surface and spray evenly. Repeat application a necessary when using this product to avoid swallowing

Other information

• store between 15-30 C (59-86F)

Inactive ingredients

Aqua, FD&C Blue No.1, FD&C Red No.40, Glycerin, Parfum.

Kills 99.99% of Germs *

* KILLS 99.9 OF MOST COMMON GERMS, BACTERIA AND VIRUSES.

Distributed by:
American Brands and More LLC,
Wood Ridge, NJ 07075

Made in TURKEY
You may also report any serious side effects to
PO Box 328, Wood Ridge, NJ 07075-328

Packaging

IMAGE
(click image for full-size original)

ABUTOL SANITIZING LEMON AND MINT
benzalkonium chloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-802
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77418-802-10 1000 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/06/2020
Labeler — ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Establishment
Name Address ID/FEI Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI 566218248 manufacture (77418-802)

Revised: 11/2020 ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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