DermaGel Clear Hand Sanitizing Gel

DermaGel Clear by

Drug Labeling and Warnings

DermaGel Clear by is a Otc medication manufactured, distributed, or labeled by Inopak. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMAGEL CLEAR- alcohol gel 
Inopak. Ltd

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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DermaGel Clear Hand Sanitizing Gel

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.
  

Warnings

• Flammable, keep away from heat or flame.
• For external use only.
  

Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.
  

Other information

May discolor certain fabrics and surfaces

Inactive ingredients

Acrylates/C10/30 Alkyl Acrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

Questions?

Call: 1-800-762-7725 or visit our website: www.inopak.com

NOT TESTED ON ANIMALS

Inopak, LTD.

Ringwood, NJ 07456

DERMAGEL CLEAR 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-131-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/03/2021	08/27/2021
2	NDC: 58575-131-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/03/2021	08/27/2021
3	NDC: 58575-131-80	800 mL in 1 POUCH; Type 0: Not a Combination Product	05/03/2021	08/27/2021
4	NDC: 58575-131-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	05/03/2021	08/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/03/2021	08/27/2021

Labeler - Inopak. Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak. Ltd		194718243	manufacture(58575-131)

Revised: 8/2021

Document Id: ca8e2059-f7ef-eb5a-e053-2995a90aef49

34390-5

Set id: c1722131-f028-baf1-e053-2a95a90a4fe0

Version: 2

Effective Time: 20210827