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Dettol First Aid Antiseptic by Fresh N Clear LLC

Medically reviewed by Drugs.com. Last updated on Jul 28, 2020.

Dosage form: liquid
Ingredients: CHLOROXYLENOL 4.8g in 15mL
Labeler: Fresh N Clear LLC
NDC Code: 79567-875

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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

Active Ingredient(s)

Chloroxylenol 4.8% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

First Aid to help prevent infection of minocutsscrapesburns

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

750ml NDC 79567-875-4

DETTOL FIRST AID ANTISEPTIC 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79567-875
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL4.8 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
WATER 
WHITE PINE OIL 
ISOPROPYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:79567-875-04750 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2020
Labeler - Fresh N Clear LLC (064116345)
Establishment
NameAddressID/FEIOperations
Fresh N Clear LLC064116345manufacture(79567-875)

 
Fresh N Clear LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.