Label: EPSOM SALT BABY BEAUTY- magnesium sulfate, unspecified granule

  • NDC Code(s): 71611-010-01, 71611-010-02, 71611-010-03, 71611-010-04
  • Packager: Click Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 23, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Magnesium Sullfate USP (Epsom Salt)

  • PURPOSE

    Internal Use ...............Saline laxative

    External Use ..............Soaking Solution

  • DOSAGE & ADMINISTRATION

    For internal Use as laxative:

    • do not exceed more than 2 doses per day
    • may be taken as a single daily dose or in divided doses
    • dissolve each dose in a full (8 ounces)of liquid
    • Age = Aduls and children 12 years and older ............Dose: 2 to 4 level teaspoons (10 to 22 grams) daily
    • Children 6 and under 12 years....................................Dose: 1 to 2 level teaspoons (5 to 10 grams) daily
    • Not recommended for children under 6 years of age.
  • INDICATIONS & USAGE

    USES

    Internal

    • Relieves occasional constipation (irregularity)
    • Generally produces bowel movements in 1/2 to 6 hours

    External - RElieves pain from minor prains and bruises

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where ther is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.

  • WARNINGS

    Warnings - Ask a doctor before use if you have:

    • kidney disease
    • a magnesium restricted diet
    • abdominal pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week

    Ask doctor or pharmacist before use if you are presently taking any other drug. take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product, do not use more than directed.

    Stop and consult a doctor if:

    • As laxative: you have rectal bleeding or fail to have a bowel movement after use.
    • This may indicate a serious condition
    • You need to use a laxative for more than 1 week.

    As a soaking solution if:

    • you have redness, irritation, swelling or infection occurs
    • hot or warm soaks should not be used by individuals with diabeted except with the advise of a pyhsician.

    If pregnant or breast-feedig , ask a health professional before use.

    Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

    EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALT CAN BE APPLIED FOR EXTERNAL USE ONLY.

  • INACTIVE INGREDIENT

    n/a

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    EPSOM SALT  BABY BEAUTY
    magnesium sulfate, unspecified granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-010
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-010-02907 g in 1 BOX; Type 0: Not a Combination Product10/19/2017
    2NDC:71611-010-031361 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
    3NDC:71611-010-01454 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
    4NDC:71611-010-041814 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/19/2017
    Labeler - Click Products LLC (080766174)
    Establishment
    NameAddressID/FEIBusiness Operations
    PRIYAL COSMETICS675482356manufacture(71611-010)