Label: EPSOM SALT SOAKING SOLUTION- magnesium sulfate granule
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Contains inactivated NDC Code(s)
NDC Code(s): 51345-099-01 - Packager: Advanced Beauty Systems, Inc.
- 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 June 20, 2012
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ACTIVE INGREDIENT
Active ingredient Purpose
Magnesium Sulfate USP (Epsom Salts)
External use Soaking solution
Internal Use Saline Laxative
Uses
External: Relieves pain from minor sprains and bruises
Internal: Relieves occasional constipation (irregularity)
generally produces bowel movement in 1/2 to 6 hours.
Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.
When using this product, do not use more than directed.
Stop use and consult a doctor if:
As a soaking solution
- you experience redness, irritation, swelling , or infection
As a laxative
- you have no bowel movements within six hours or experience rectal bleeding-these could be signs of a serious condition
- you need a laxative for more than a week
Warnings:
Laxative
- Do not give to children under six years of age except under the advice and supervision of a physician.
- For occasional use only. Serious side effects from prolonged use or overdose may occur.
Do not take this product except under the advice and supervision of a physician if you:
- Have kidney disease
- Are taking prescription medication
- Have a magnesium restricted diet
Ask a doctor before if you have
As a soaking solution
- redness or swelling present
- evidence of an infection
- diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physician
As a laxative
- Stomach pain
- Nausea
- Kidney disease
- A sudden change in bowel habits that lasts over 2 weeks
If pregnant or breast feeding, consult a physician before use
Other information
Dissolve before use
Directions
- Do not exceed more than 2 doses per day, if neccessary repeat dosage in 4 hours
For External use
As a soaking solution: pour 2 cups of Epsom Salts under warm, running bath water. Soak for 20 minutes for to relieve sore,tired muscles.
As a warm compress: Dissolve 1 cup of Epsom Salts in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30 minutes to reduce pain and and swelling. Repeat as needed.
For internal use
As a laxative 2-4 level teaspoons dissolved in a full glass (8oz) of water.
adults and children 12 years and older
children 6 to 12 years of age 1-2 level teaspoons dissolved in a full glass (8oz) of water.
not recommended for children under 6 years of age
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EPSOM SALT SOAKING SOLUTION
magnesium sulfate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51345-099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE 2.72 kg in 2.72 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51345-099-01 2.72 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/13/2012 Labeler - Advanced Beauty Systems, Inc. (129986613) Registrant - Giles Chemical, a division of Premier Magnesia, LLC (003162435) Establishment Name Address ID/FEI Business Operations Giles Chemical, a division of Premier Magnesia, LLC 003162435 manufacture
