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 |
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ACTIVE INGREDIENT
Active Ingredient ..................................................................... Purpose
Magnesium Sulfate USP (Epsom Salt)
Internal Use ....................................................................... Saline Laxative
External Use .................................................................... Soaking Solution
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
Age Dose adults and children 12 years and older 2 to 4 level teaspoons (10 to 20 grams) daily children 6 to under 12 years 1 to 2 level teaspoons (5 to 10 grams) daily Not recommended for children under 6 years of age.
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GREEN TEA CHAMOMILE NATURAL EPSOM SALT
magnesium sulfate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70410-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE 10 g in 10 g Inactive Ingredients Ingredient Name Strength CHAMOMILE (UNII: FGL3685T2X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70410-004-01 454 g in 1 PACKAGE; Type 0: Not a Combination Product 01/26/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/26/2016 Labeler - Point Guard Marketing Inc. (959973074) Establishment Name Address ID/FEI Business Operations Anhui Twowin Machinery Imp. & Exp. Co., Ltd. 421251758 manufacture(70410-004)