Galentic Hydrogel: Package Insert and Label Information

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.

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

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
PRINCIPAL DISPLAY PANEL -- 84.7 g Tube Label
(click image for full-size original)
GALENTIC HYDROGEL
glycerin gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
ALOE VERA LEAF
DIAZOLIDINYL UREA
METHYLPARABEN
PROPYLENE GLYCOL
PEG-60 HYDROGENATED CASTOR OIL
PROPYLPARABEN
WATER
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50382-013-15 24 TUBE in 1 CASE contains a TUBE
1 84.7 g in 1 TUBE This package is contained within the CASE (50382-013-15)
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 Operations
Galentic Pharma (India) Private Limited 650970176 ANALYSIS (50382-013), manufacture (50382-013), PACK (50382-013), REPACK (50382-013), STERILIZE (50382-013)

Revised: 06/2018 Galentic Pharma (India) Private Limited

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