GALENTIC HYDROGEL- glycerin gel 
Galentic Pharma (India) Private Limited

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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Galentic's Moisturizing Wound Hydrogel

Active Ingredient

Glycerin 20.0%

Purpose

Skin Protectant

•  USES

Temporarily protects minor

•  WARNINGS

For external use only

•  DO NOT USE ON

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

•  WHEN USING THIS PRODUCT

Do not get into eyes

•  STOP USE AND ASK A DOCTOR IF

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again a few days

•  KEEP OUT OF REACH OF CHILDREN

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

•  DIRECTIONS

•  OTHER INFORMATION

Store at room temperature

•  INACTIVE INGREDIENT

Allantoin, Aloe Barbadensis gel, Diazolidinyl urea, Methylparaben, PEG-4 Olivate, PEG-60 Hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium polyacrylate, Tetrasodium EDTA, Tocopheryl acetate

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C,
Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 84.7 g Tube Label

Galentic's
Moisturizing Wound Hydrogel

Galentic

Net Wt. 3 oz. (84.7 g)

PRINCIPAL DISPLAY PANEL - 84.7 g Tube Label
GALENTIC HYDROGEL 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-013
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
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-013-1524 in 1 CASE04/14/2014
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 finalpart34604/14/2014
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-013) , manufacture(50382-013) , PACK(50382-013) , REPACK(50382-013) , STERILIZE(50382-013)

Revised: 6/2018
Document Id: 2e373cb4-cc06-4e21-a32e-52af72cd6f0f
Set id: 4b634f76-180a-4d50-8eb5-8ec856247d9e
Version: 5
Effective Time: 20180619
 
Galentic Pharma (India) Private Limited