FDA Label for Rugby Hydrocortisone With Aloe
View Indications, Usage & Precautions
Rugby Hydrocortisone With Aloe Product Label
The following document was submitted to the FDA by the labeler of this product Rugby. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
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RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
Active Ingredient
Hydrocortisone 1%
Purpose
Antipruritic (anti-itch)
Uses
- for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
- and for external anal and genital itching.
Warnings
For external use only.
Avoid contact with eyes.
Do Not Use
- if you have a vaginal discharge. Consult a doctor.
When Using This Product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occurs again within a few days
- bleeding occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
For itching associated with minor skin irritations, inflammation, and rashes:
Adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
- when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor
For external anal and genital itching:
Adults and children 12 years of age and older:
Children under 12 years of age: Consult a doctor
Other Information
Store at 15 to 30°C (59 to 86°F).
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients
aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA
Questions Or Comments?
1-800-645-2158
Principal Display Panel - 28 G Tube Carton
Rugby®
NDC 0536-1277-80
Maximum Strength
Hydrocortisone Cream 1%
with Aloe
Compare to the
active ingredient of
Cortizone-10® with Aloe*
Fast itch relief
NET WT 1 OZ (28 g)
* Please review the disclaimer below.