DR MINERAL ANTI-ITCH SPRAY- sodium chloride spray

Dr MINERAL Anti-Itch Spray by

Drug Labeling and Warnings

Dr MINERAL Anti-Itch Spray by is a Otc medication manufactured, distributed, or labeled by MineralBio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

[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

WHEN USING

[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

[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 CHILDREN

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

ACTIVE INGREDIENT

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

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

DR MINERAL ANTI-ITCH SPRAY 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50499-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.7 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	98 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50499-200-10	100 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/20/2010

Labeler - MineralBio (631154981)

Registrant - MineralBio (631154981)

Establishment
Name	Address	ID/FEI	Business Operations
MineralBio		631154981	manufacture