HYDRO GEL- glycerin 20% gel 
Trifecta Pharmaceuticals USA LLC

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Globe Hydro Gel

Drug Facts

Active Ingredient

Glycerin 20%

Purpose

Skin Protectant

Uses

Stop use and ask a doctor

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

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

4852 GLOBE HYDROGEL 3OZ 062523 CDER

HYDRO GEL 
glycerin 20% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-127-031 in 1 BOX08/23/2023
184.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01608/14/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2024
Document Id: 0f4e25fa-bccd-b725-e063-6294a90ac340
Set id: 02e8e5d0-7844-39fe-e063-6394a90a57e1
Version: 2
Effective Time: 20240119
 
Trifecta Pharmaceuticals USA LLC