ADCLEAN MEDICAL GEL- isopropyl alcohol gel 
Adfast Corp

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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ADCLEAN Medical Gel

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 (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Purified water = 26.25 v%
  3. Rapidgel EZ1 = 3.00 v%
  4. Hydrogen peroxide 29% = 0.45 v%
  5. Fragrance = 0.30 v%

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)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

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

Do not use

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

Other information

Inactive ingredients

Water

Polyethylene Glycol

Acrylate Polymer

Hydrogen Peroxide

Fragrance

Package Label - Principal Display Panel

78335-002

10L Medical Gel

470ml Medical Gel

ADCLEAN MEDICAL GEL 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78335-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 3 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 26.25 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.3 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78335-002-0110000 mL in 1 JUG; Type 0: Not a Combination Product07/16/2020
2NDC:78335-002-02470 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - Adfast Corp (203870543)
Registrant - Dan Garnett (203870543)
Establishment
NameAddressID/FEIBusiness Operations
Adfast Corp203870543manufacture(78335-002)

Revised: 1/2022
Document Id: d6701eaf-3f18-6cd4-e053-2a95a90af21c
Set id: aa918b1f-8e7f-10d3-e053-2995a90a8e77
Version: 2
Effective Time: 20220125
 
Adfast Corp