HYDRO GEL- glycerin 20% gel

Hydro Gel by

Drug Labeling and Warnings

Hydro Gel by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Glycerin 20%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns
• Maintains a moist wound environment
• Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care.

Stop use and ask a doctor

• condition worsens or does not improve within 10-14 days

Keep out of the reach of children

If swallowed get medical help or contact Poison Control Center right away

When Using this product

Avoid contact with eyes

Directions

• Apply liberally as often as necessary to cover affected areas.
• If gauze is used as a wound covering, moisten first.
• Children under 6 months: Consult a doctor before use

Warning

For External Use Only

DO NOT USE

Do not use on Deep pumcture wounds or Animal Bites

Other information

Store at room temperature 15°-30°C (59°-86°F)

**Tamper evident. Do not use if seal is damaged

Inactive Ingredients

Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate

Questions or Comments

Call Toll Free 1-888-296-9067

Distributed By

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRO GEL 
glycerin 20% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-4 OLEATE (UNII: 9QL37EC4J7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-127-03	1 in 1 BOX	08/23/2023
1		84.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/14/2023

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)