GREEN TEA CHAMOMILE NATURAL EPSOM SALT (MAGNESIUM SULFATE) POWDER [POINT GUARD MARKETING INC.]

GREEN TEA CHAMOMILE NATURAL EPSOM SALT (MAGNESIUM SULFATE) POWDER [POINT GUARD MARKETING INC.]
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NDC 70410-004-01
Set ID 2a471d7a-d6dd-5773-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Point Guard Marketing Inc.
Generic Name
Product Class
Product Number
Application Number PART334
  • ACTIVE INGREDIENT

    Active Ingredient ..................................................................... Purpose

    Magnesium Sulfate USP (Epsom Salt)

    Internal Use ....................................................................... Saline Laxative

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

  • PURPOSE

    Uses (Internal)

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

    Uses (External)

    • Relieves pain from minor sprains and bruises

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions - For Internal Use as a 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
     AgeDose 
     adults and children 12 years and older2 to 4 level teaspoons (10 to 20 grams) daily 
     children 6 to under 12 years1 to 2 level teaspoons (5 to 10 grams) daily 

    Not recommended for children under 6 years of age.

  • INDICATIONS & USAGE

    Natural Epsom Salt

    Magnesium Sulfate U.S.P.

    Soaking Solution

    Saline Laxative

    Soothes Minor Aches, Sprains & Sore Muscles

    Calming & Rejuvenating

    SORE FEET RELIEF: Add one cup of Amoray Care® Epsom Salt to one gallon of warm water and soak for at least 5 minutes at a time.

    BATH SOAK: Add two cups of Amoray Care® Epsom Salt under warm running bath water to release its gentle aroma. Amoray Care® Epsom Salt helps relieve tension and provides a soothing, relaxing experience.  Soak for at least 20 minutes.

    First Aid Compress: Dissolve 2 cups of Amoray Care® Epsom Salt into two cups of hot water to make a compress, apply as a wet dressing with a towel to: soothe bruises & sprains, take the sting out of insect bites, draw out splinters, alleviate pain from sports and overexertion.

    Kkeep out of reach of children.  Where prompt relief is not obtained or where there 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.

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

    Store in a cool, dry place out of direct sunlight. Package sold by weight not volume, some settling may occur during shipment. If caking occurs, tap pouch gently to free granules.

  • 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 a 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 soaking solution: • you have redness, irritation, swelling, or infection occurs • hot or warm soaks should not be used by individuals with diabetes except with the advice of a physician

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

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

  • INACTIVE INGREDIENT

    Ingredients: 

    Natural Magnesium Sulfate

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GREEN TEA CHAMOMILE NATURAL EPSOM SALT 
    magnesium sulfate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70410-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE10 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70410-004-01454 g in 1 PACKAGE; Type 0: Not a Combination Product01/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/26/2016
    Labeler - Point Guard Marketing Inc. (959973074)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Twowin Machinery Imp. & Exp. Co., Ltd.421251758manufacture(70410-004)

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