OTC Medication Information: KAI KLEAN

KAI KLEAN- alcohol liquid
Bender Consulting Ltd

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.

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label — Principal Display Panel

100 ml spray label
(click image for full-size original)
100 ml flip top label
(click image for full-size original)
300ml label
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1000ml label
(click image for full-size original)
1800ml label
(click image for full-size original)
2000ml label
(click image for full-size original)
2700ml label
(click image for full-size original)

KAI KLEAN
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74918-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74918-002-27 2700 mL in 1 BOTTLE None
2 NDC:74918-002-20 2000 mL in 1 BOTTLE None
3 NDC:74918-002-18 1800 mL in 1 BOTTLE None
4 NDC:74918-002-10 1000 mL in 1 BOTTLE, PUMP None
5 NDC:74918-002-03 300 mL in 1 BOTTLE None
6 NDC:74918-002-01 100 mL in 1 BOTTLE None
7 NDC:74918-002-00 100 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 05/08/2020
Labeler — Bender Consulting Ltd (036411509)
Registrant — Bender Consulting Ltd (036411509)
Establishment
Name Address ID/FEI Operations
BINH TAY LICO 555362337 manufacture (74918-002), pack (74918-002)

Revised: 05/2020 Bender Consulting Ltd

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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