FDA Label for Ana Cool Rapid Soothing Cooling Formula
View Indications, Usage & Precautions
Ana Cool Rapid Soothing Cooling Formula Product Label
The following document was submitted to the FDA by the labeler of this product Ana-cool, Llc. 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.
Active Ingredients:
Hydrocortisone 1.0%
Uses:
- Temporarily relief of external anal itching
- Temporary relief of itching associated with minor skin irritations and rashes
- Other uses of this product should be only under the advice and supervision of a doctor
Warnings:
- For external use only.
Do Not Use For
the treatment of diaper rash. Consult a doctor.
When Using This Product,
• avoid contact with the eyes • 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
• bleeding occurs • condition worsen • symptoms persist for more than 7 days or clear up occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Centre right away
Directions:
- Adults: cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before the applicationof this product
- Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
- Children under 12 years of age: do not use, consult a doctor
Other Information
Store at 20 - 25 °C (68-77°F)
Other Ingredients:
Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, cetearcth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.
Package Labeling:
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