Active Ingredient
Phenylephrine HCL 0.25%
Zinc Oxide 12.50%
Makesense
FDA Label NDC 69020-205
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cherry Hill Sales Co for the product Makesense (NDC 69020-205). 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 active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vasoconstrictor
Astringent
Uses
For temporary relief of local anorectal burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.
Warnings
For external use only
Do Not Use
■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash
Stop Use And Ask A Doctor If
■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ Do not exceed the recomended daily dosage unless directed by a doctor ■ In case of bleeding, consult a doctor promptly ■ Certain persons can develop allergic reactions to ingredients in this product ■ If the symptom treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult doctor ■ If you are pregnant, do not use this product without first consulting doctor.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
■ Cleanse affected area with mild soap and warm water, rinse thorouhly ■ Dry by patting or blotting with toilet tissue
or soft cloth before applying ■ Cover the entire affected area with a thin layer 1 to 3 times daily ■ Children under 12 years of age need
to consult doctor before using this product
Other Information
■ store at 68-77F (20 to 25C) ■ See Lot No. and Exp. Date: on box and crimp of tube
Inactive Ingredients
Lanolin, Methylparaben, Ozokerite, Paraffin, Propylparaben, White Petrolatum
Package Label
Image Description (Hmmhrdlbl)
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