FDA Label for No More Products
View Indications, Usage & Precautions
No More Products Product Label
The following document was submitted to the FDA by the labeler of this product Pranicura Group 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.
Other
Drug Facts
Otc - Active Ingredient
Active Ingredients
Glycerin 25%
Kaolin 12.5%
Calamine 12.5%
Menthol 1%
Otc - Purpose
Purposes
Glycerin ....................................................Protectant
Kaolin .........................................Protectant/Anti-Itch
Calamine ....................................Protectant/Anti-Itch
Menthol .....................................................Analgesic
Indications & Usage
Uses • Helps relieve the itching and discomfort associated with anorectal disorders •
Provides temporary relief from the symptoms of perianal skin irritation • For the temporary
relief of itching associated with moist anorectal conditions • For the temporary relief of
irritation and burning
Warnings
Warnings
For rectal use only
Do not use unless a prior doctor’s diagnosis of anorectal condition has been made
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days
• allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain,
other symptoms develop or increase • Do not put this product into the rectum by using fingers or any
mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product
because they interfere with the ability of this product to adhere properly to the skin area.
If pregnant or breastfeeding, 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 right away
Dosage & Administration
Directions
Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply a pea size amount of cream externally to the anal area and to the inner rim of the anus,
not deep into the rectum. • Children under 12 years of age: consult a doctor • Apply externally to the
affected area once or twice daily when pain or irritation is present.
Other Safety Information
Other Information: Do not use if tube seal is cut, broken or missing. • store at 15-30° C (59-86° F)
Inactive Ingredient
Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,
Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol
Otc - Questions
Questions or Comments? Email: [email protected]
No More Product Labeling
No More Products
Net Wt. 1.25oz (35g)
Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX 78566
www.nomoreproducts.com
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RES
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