GALENTIC HYDROGEL- glycerin gel

Galentic Hydrogel by

Drug Labeling and Warnings

Galentic Hydrogel by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Glycerin 20.0%

Purpose

Skin Protectant

  USES

Temporarily protects minor

• Cuts
• Scrapes
• Burns

  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

• Apply as needed.
• Children under 6 months: Ask a doctor

  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

SPL UNCLASSIFIED SECTION

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)

• With Vitamin E & Aloe Vera
• Clean and Greaseless

INGREDIENTS AND APPEARANCE

GALENTIC HYDROGEL 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-013
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-013-15	24 in 1 CASE	04/14/2014
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 final	part346	04/14/2014

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	ANALYSIS(50382-013) , manufacture(50382-013) , PACK(50382-013) , REPACK(50382-013) , STERILIZE(50382-013)