Active Ingredient
Zinc Oxide 30.6%
Secura Extra Protective Cream
FDA Label NDC 69740-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smith & Nephew Medical Ltd for the product Secura Extra Protective Cream (NDC 69740-325). 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, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
- skin protectant
- helps treat and prevent diaper dermatitis
- protects minor skin irritation associated with diaper dermatitis and helps seal out wetness
Warnings
- For external use only
- Avoid contact with the eyes
- Not to be applied over deep or puncture wounds, infections, or lacerations
- If condition worsens or does not improve within 7 days, contact a doctor
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Certer immediately
Directions
- change wet and soiled diapers, garments and linens promptly
- cleanse the affected area and allow to dry
- apply cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
Other Information
Store at controlled room temperature 59oF-86oF (15oC-30oC)
Inactive Ingredients
petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben
Questions Or Comments?
1 800 876-1261
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