OTC Medication Information: Clementine Hand Sanitizer

CLEMENTINE HAND SANITIZER- benzalkonium chloride liquid
Mangiacotti, Inc

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 Fatcs

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin ∙Recommended for repeated use

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops, or if condition 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

Spray a small amount into palm of hand-Rub thoroughly over all surfaces of both hands-Rub hands together briskly until dry

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance with essential oils

Clementine hand sanitizer spray 0.5oz/15ml (42926-162-15)

42926-162-15_2
(click image for full-size original)

CLEMENTINE HAND SANITIZER
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42926-162
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CETRIMONIUM CHLORIDE
LAURTRIMONIUM CHLORIDE
DIHYDROXYETHYL COCAMINE OXIDE
GLYCERETH-17 COCOATE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42926-162-15 1 BOTTLE, SPRAY in 1 PACKAGE contains a BOTTLE, SPRAY
1 15 mL in 1 BOTTLE, SPRAY This package is contained within the PACKAGE (42926-162-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/14/2014 08/31/2024
Labeler — Mangiacotti, Inc (078850804)

Revised: 01/2023 Mangiacotti, Inc

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.

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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