Active Ingredients
White Petrolatum 50%
Zinc Oxide 10%
Soothe And Cool Protect
FDA Label NDC 53329-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Inc. for the product Soothe And Cool Protect (NDC 53329-004). 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 ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
■ Temporarily relieves skin irritation including itching, burning, and discomfort
■ Temporarily forms a protective coating over inflamed tissues to help prevent drying
■ Protects minor skin irritation associated with diaper rash and helps seal out wetness
Warnings
For external use only
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- Do not get into the eyes
Stop Use And Ask A Doctor If
- Condition worsens or does not improve within 7 days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- gently cleanse and dry affected area
- apply liberally to affected area as needed
Other Information
Protect from freezing, avoid excessive heat.
Inactive Ingredients
Allantoin, Benzethonium Chloride, Eugenia Caryophyllus (Clove) Flower Oil, Zea Mays (Corn) Starch, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Xanthan Gum
Other
www.medline.com
Manufactured in USA for Medline Industries, Inc.,
Mundelein, IL 60060 USA.
1-800-MEDLINE
Package Label.Principal Display Panel
NDC: 53329-004-10
SOOTHE & COOL®
PROTECT
ZINC OXIDE
SKIN PASTE
- Provides a thick, protective barrier
- Enhanced with vitamins A & E
Net Wt. 2.5 oz (71 g)
REF MSC095450
Label (Label)
* Please review the disclaimer below.
