Otc - Active Ingredient
Active ingredients
Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White petrolatum 15%
Cvs Health Cream
FDA Label NDC 69571-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Cvs Health (NDC 69571-010). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Glycerin 14.4% ...........................Protectant
Phenylephrine HCl 0.25% .............Vasoconstrictor
Pramoxine HCl 1%........................Local anesthetic
White petrolatum 15%..................Protectant
Indications & Usage
Uses •for temporary relief of pain, soreness and burning •helps relieve
the local itching and discomfort associated ith hemorrhoids
•temporarily provides a coating for f of anorectal discomforts
•temporarily protects the inflamed irritated anorectal surface to help make
bowel movements less painful •temporarily shrinks hemorrhoidal tissue
Warnings
Warnings
For external use only.
When using this product •do not put this product into the rectum by
using fingers or any mechanical device or applicator •do not exceed
recommended daily dosage unless directed by a doctor
Ask a doctor before use ifyou have
•heart disease •high blood pressure •thyroid disease •diabetes
•trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are presently taking a
prescription drug for high blood pressure or depsression
Stop use and ask a doctor if
•bleeding occurs •condition worsens or does not improve within 7 days
•if the symptoms being treated do not subside or if redness, irritation,
swelling, pain or other symptoms develop or increase. Some people can
develop allergic reactions to ingredients in this product.
If pregnant or breast-feeding, 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 with mild soap and water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
•apply externally to the affected area up to 4 times daily, especially at night or in the
morning or after each bowel movement.
Children under 12 years of age: consult a doctor.
Storage And Handling
Other information store at room temperature 68° - 77° F (20° - 25° C)
Inactive Ingredient
Inactive ingredients aloe barbadensis leaf extract, carboxymethyllcellulose
sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene
glycol, propylparaben, stearic acid, tween 80, water, xanthan gum
Otc - Questions
Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
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