Label: FORMULA H- glycerin 25% cream

  • Category: HUMAN OTC DRUG LABEL

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, 2015

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  • ACTIVE INGREDIENT

    Glycerin 25%

  • PURPOSE

    Protectant

  • USES

    • Helps relieve hemorrhoids
  • Keep out of the reach of children

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Apply to the affected area up to 6 times daily or after each bowel movement.

  • INACTIVE INGREDIENTS

    Water, Aloe Vera, Arnica, Sweet Almond Oil, Horse Chestnut Seed Extract, Ginkgo Biloba Leaf Extract, Evening Primrose Oil, Apricot Kernel Oil, Rose Hips Extract, Tea Tree Essential Oil, Grapefruit Seed Extract

  • Questions?

    Call toll-free from US & CA +1-844-881-2882 or visit www.deserving-health.com

  • WARNINGS

    For external use only.

  • When using this product

    When using this product • do not get into eyes.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms last more than 7 days, or clear up and occur again within a few days, consult a doctor.
    • In case of bleeding, consult a doctor promptly.
  • When using

    • Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • PRINCIPAL DISPLAY PANEL

    Box 50mL

    Label 50mL

    Box 15mL

    Label 15mL

  • DO NOT USE

    Do not use if you are allergic to plants of the Asteraceae/ Compositae/Daisy family. Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

  • INGREDIENTS AND APPEARANCE
    FORMULA H 
    glycerin 25% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-007
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GINKGO (UNII: 19FUJ2C58T)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-007-041 in 1 CARTON06/18/2015
    150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:69711-007-031 in 1 CARTON06/18/2015
    215 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/18/2015
    Labeler - Biological Health Group Corporation (079767886)
    Registrant - Biological Health Group Corporation (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deserving Health International Corp202617023manufacture(69711-007)
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