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Dr MINERAL Anti-Itch

Dosage form: spray
Ingredients: SODIUM CHLORIDE 0.7mL in 100mL, MENTHOL 0.05mL in 100mL
Labeler: MineralBio
NDC Code: 50499-300

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.

[Uses]
Dr. Mineral Anti-Itch Spray is useful for the temporary relief of itching associated with irritation, rashes and inflammation due to
- skin dryness - eczema - psoriasis - photo sensitivity - jewelry - insect bites - soaps and detergents - cosmetics - poison ivy, oak or sumac - seborrheic dermattis - Other use of this product ask a doctor

[Directions]
Apply when needed not more than 5-6 times a day.
- spray 2-3 times when use
- Children under 2 years, do not use: ask a doctor

[Warnings] For external use only.
- Do not use in or near the eyes.  For diaper rash: ask a doctor
- Stop use and ask a doctor if
      - condition worsens
      - symtoms persist for more than 7 days or clear up and occur again within a few days

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

[Active Ingredients} Sodium Chloride 0.7%, Menthol 0.05%

[Storage]
Store at a room temperature.  Protect from freezing and excessive heat.
Expire: 02.25.2012

[Inactive Ingredients] Water, Glycerin, Grapefruit Seed Extract, Zinc Chloride, Cupric Chloride, Germanium Dioxide, Ethanol, Polysorbate 20

DR MINERAL ANTI-ITCH 
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50499-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE0.7 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.05 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER98 mL  in 100 mL
GLYCERIN0.5 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:50499-300-10100 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/20/2010
Labeler - MineralBio (631154981)
Registrant - MineralBio (631154981)
Establishment
NameAddressID/FEIOperations
MineralBio631154981manufacture

Revised: 02/2010
Document Id: 6ed10c93-b0f4-4965-9417-c81bf2be4650
Set id: 39c07ac6-f628-4864-a013-13a784915df7
Version: 1
Effective Time: 20100220
 
MineralBio

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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