Otc - Active Ingredient
ACTIVE INGREDIENTS: Apis mellifica 12X, Belladonna 12X, Calcarea carbonica 12X, Medusa 12X, Mezereum 12X, Rhus toxicodendron 12X, Astacus fluviatilis 15X, Chloralum 15X.
Itchy Gone
FDA Label NDC 57520-0777
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Itchy Gone (NDC 57520-0777). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.
Warnings
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
For topical use only.
Dosage & Administration
DIRECTIONS: Apply topically to affected area 4 to 6 times daily.
Inactive Ingredient
INACTIVE INGREDIENTS: Aloe, Biosaccharide gum-1, Carbomer, Ethanol, Glycerin, NaPCA, Purified water, Sodium hydroxymethylglycinate, Tromethamine.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away.
Indications & Usage
INDICATIONS: For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.
Otc - Questions
Dist. By:
MedCare Group
Boothwyn, PA 19060
302-260-3111
www.medcaregroups.com
Package Label.Principal Display Panel
MEDCARE
Itchy Gone
HOMEOPATHIC
Net Wt. 2 OZ
Itchy Gone (Mm1)
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