DETTOL FIRST AID ANTISEPTIC- chloroxylenol liquid 
Fresh N Clear 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.

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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)

labelChloroxylenol 4.8% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Label

Warnings

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

Do not use

First Aid to help prevent infection of minocutsscrapesburns Direction of use

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

750ml label

750ml NDC 79567-875-4

DETTOL FIRST AID ANTISEPTIC 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79567-875
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL4.8 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
WATER (UNII: 059QF0KO0R)  
WHITE PINE OIL (UNII: HA5CX6676U)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79567-875-04750 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/2020
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/FEIBusiness Operations
Fresh N Clear LLC064116345manufacture(79567-875)

Revised: 7/2020
Document Id: ab8a1e8a-9c34-e334-e053-2a95a90a15d0
Set id: ab8cd9d1-9ddc-c458-e053-2995a90a8895
Version: 1
Effective Time: 20200728
 
Fresh N Clear LLC