Active Ingredient
Calendula Officinalis 1X HPUS 4%
Homeopathic active ingredient
Radthary Foreskin Relief Cream
FDA Label NDC 87957-025
13 label sections · Submitted to the FDA by Hubei Minxin Pharmaceutical Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hubei Minxin Pharmaceutical Co., Ltd. for the product Radthary Foreskin Relief Cream (NDC 87957-025). 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, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Soothes irritated skin
Uses
▪ temporarily helps relieve redness, itching and mild irritation of delicate male skin
▪ helps relieve chafed, chapped or cracked skin
Warnings
For external use only.
Do Not Use
▪ on children under 2 years of age unless directed by a doctor
▪ on deep or puncture wounds
▪ if you are allergic to any ingredient in this product
When Using
▪ avoid contact with the eyes
▪ if contact occurs, rinse thoroughly with water
Stop Use
▪ symptoms persist for more than 7 days
▪ rash or irritation develops
▪ the condition worsens after initial improvement
Ask Doctor
▪ symptoms persist for more than 7 days
▪ rash or irritation develops
▪ the condition worsens after initial improvement
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▪ cleanse the affected area with mild soap and water, pat dry
▪ dispense 2 pumps of cream onto clean fingers
▪ apply gently to the affected area 1 to 2 times daily
▪ massage until fully absorbed
▪ for first-time users, do a small patch test before full use
Other Information
▪ store at 59°F to 86°F (15°C to 30°C)
▪ claims based on homeopathic materia medica; not evaluated by the FDA for efficacy
Inactive Ingredients
Bentonite, Caprylic/Capric Triglyceride, Cedarwood Oil, Cetyl Alcohol, Colloidal Oatmeal, Cottonseed Oil,Glycerin, Glyceryl Stearate SE,Jojoba Oil, Lavender Oil
Principal Display Panel
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