DermaGel Hand Sanitizing Gel

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin.
Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. In case of eye contact, rinse eyes 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.

Directions

Apply liberally to hands to cover all surfaces
Rub hands together until dry.
Supervise children under 6 years old.
Not recommended for infants.

Other information

Store between 15 - 30°C (59-86°F)
May discolor certain fabrics and surfaces.

Inactive ingredients Water, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Alpha-tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Juice, FD&C Yellow 5, FD&C Blue 1.

Inopak LTD.

Ringwood, NJ 07456

1-800-762-7725 • www.inopak.com

DermaGel®

HAND SANITIZING GEL with moisturizers

70% Alcohol with ALOE VERA & VITAMIN E

33.8 fl. oz. (1000 mL)

DermaGel Green-1000mL

DERMAGEL HAND SANITIZING
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58575-130
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/01/1990

Labeler - Inopak. Ltd (194718243)

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