Other
Drug Facts
No More Products Cream
FDA Label NDC 67676-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sarati International, Inc for the product No More Products (NDC 67676-008). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 useunless a prior doctor’s diagnosis of anorectal condition has been made
When using this productdo 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 sizeamount of cream
externallyto 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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