DERMAGEL HAND SANITIZING- alcohol gel

DermaGel by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Keep out of reach of children.

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.

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.
  

Other Information

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

May discolor certain fabrics and surfaces.

Stop use and ask a doctor

if irritation and redness develop or if condition persists more than 72 hours.

Directions

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

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E

DermaGel Product Label

DermaGel®

5025-NB               instant waterless

Rev. 1.01              HAND SANITIZING GEL

800ml                    with moisturizers             5025-404-NB

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 70% v/v …………….. 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 eyes with water.

Stop use and ask a doctor if irritation and redness develop 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. 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/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E

Questions?

Call: 1-800-762-7725                                                                       Inopak, LTD.

www.inopak.com            NOT TESTED ON ANIMALS           Ringwood, NJ 07458

DermaGel Case

DermaGel®                          5025-CS  Rev. 1.0

WATERLESS HAND SANITIZING GEL

O   80/2 oz Bottles          O   24/4 oz Bottles                          O  24/8oz Bottles                            O  16/18 oz Bottles

    5025-480-02                 5025-450-03                                5025-440-03                                     5025-430-02

 040232 65060 4               040232 65059 8                        040232 65058 1                                040232 65057 4             

O   4/1 gal. Bottles         O   8/1000ml Pouches                      O  12/800ml Pouches                   O  12/800ml Bag/Box

      5025-420-02                 5025-L1000                                    5025-404-NB                              5025-404                     

     040232 65053 6             040232 65054 3                              040232 65055 0                          040232 65056 7

MADE

IN THE USA         Inopak, LTD.       Ringwood, NJ 07456        1-800-762-7725 www.inopak.com        INOPAK

INGREDIENTS AND APPEARANCE

DERMAGEL  HAND SANITIZING
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-130
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-130-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/1990
2	NDC: 58575-130-04	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/1990
3	NDC: 58575-130-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/1990
4	NDC: 58575-130-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/1990
5	NDC: 58575-130-37	3785 mL in 1 JUG; Type 0: Not a Combination Product	09/01/1990
6	NDC: 58575-130-65	650 mL in 1 BAG; Type 0: Not a Combination Product	09/01/1990
7	NDC: 58575-130-80	800 mL in 1 BAG; Type 0: Not a Combination Product	09/01/1990	02/01/2020
8	NDC: 58575-130-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/01/1990	02/01/2020
9	NDC: 58575-130-81	800 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/1990
10	NDC: 58575-130-82	1000 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/1990

Labeler - Inopak. Ltd (194718243)

Registrant - Inopak. Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak. Ltd		194718243	manufacture(58575-130)