KLEANMANN – Hand Sanitizer and Surface Disinfectant: Package Insert and Label Information

KLEANMANN — HAND SANITIZER AND SURFACE DISINFECTANT- benzalkonium chloride and didecyldimonium chloride spray
Lamer Group LLC

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.

This is a hand sanitizer and surface disinfectant manufactured, tested, and registered in the EU.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation):

  1. BAC (Benzalkonium Chloride) less than 1.6%
  2. DDAC (Didecyldimonium Chloride) less than 0.4%
  3. Purified water

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

EU OTC Information
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BAC (Benzalkonium Chloride) less than 1.6% v/v Purpose: Skin Antiseptic:
DDAC (Didecyldimonium Chloride) less than 0.4% v/v Purpose: Food Contact Sanitizer

Purpose

Antiseptic, Hand Sanitizer Spray and Surface Disinfectant

Use

For hand and surface sanitizing to decrease harmful bacteria and viruses on the skin or frequently touched objects. Recommended for repeated use.

Warnings

Do not use

  • Do not use in eyes. If contact occurs, flush thoroughly with water.

Stop use and contact a doctor if redness or irritation develops and persists for more than 72 hours.

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

Directions

For hand disinfection, rub the solution carefully into your palms for 30 seconds. Clean and disinfect frequently touched objects and surfaces by spraying directly on them.

Inactive ingredients

purified water

Package Label — Principal Display Panel

120 ml NDC: 00000-000-00

120ml Label
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KLEANMANN — HAND SANITIZER AND SURFACE DISINFECTANT
bac (benzalkonium chloride), ddac (didecyldimonium chloride) spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80472-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.91 g in 120 mL
DIDECYLDIMONIUM CHLORIDE (DIDECYLDIMONIUM) DIDECYLDIMONIUM CHLORIDE 0.47 g in 120 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80472-001-01 120 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 10/01/2020
Labeler — Lamer Group LLC (117644884)

Revised: 01/2022 Lamer Group LLC

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