FDA Label for Bottoms Up Health
View Indications, Usage & Precautions
Bottoms Up Health Product Label
The following document was submitted to the FDA by the labeler of this product Centura Pharmaceuticals Inc. 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
Calamine 15%
Glycerin 35%
Lidocaine 5%
Witch Hazel 10%
Purpose
Protectant, Protectant, Anesthetic, Protectant
Uses
Helps relieve the pain, burning, soreness and itching associated with inflamed hemorrhoidal tissue and other anorectal disorders.
Temporarily protects inflamed and irritated anorectal surface to help make bowel movements less.
Warnings
For external use only
Stop Use And Ask A Doctor If
■ the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase ■ condition worsens or does not improve within 7 days
Allergy Alert
Certain persons can develop allergic reactions to ingredients in this product.
Other Warnings
Do not exceed the recommended dose unless directed by a doctor.
In case of bleeding, consult a doctor promptly.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding
Ask a health professional before use.
Directions
Adults and children over 12 years old ■ Apply externally to affected area up to 6 times a day or after each bowel movement
■ Clean affected area with mild soap and warm water, rinse thoroughly and gently dry by patting or blotting with toilet tissue or a soft cloth before using this product.
■ Children under 12 years of age: consult a doctor.
Other Information
Store at room temperature and away from direct sunlight.
Inactive Ingredients
Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Behentrimonium Methosulfate, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Glyceryl Stearate, lsopropyl Palmitate, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Silica.
Questions
813-666-7867
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