GALENTIC HYDROGEL (GLYCERIN) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

  • Home
  • GALENTIC HYDROGEL (GLYCERIN) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

GALENTIC HYDROGEL (GLYCERIN) GEL [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
PDF | XML
NDC 50382-013-15
Set ID 4b634f76-180a-4d50-8eb5-8ec856247d9e
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number PART346
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs