Label: GALENTIC HYDROGEL- glycerin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 19, 2018

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  • 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
    PRINCIPAL DISPLAY PANEL - 84.7 g Tube Label
  • INGREDIENTS AND APPEARANCE
    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)
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