Active Ingredient
Dimethicone 5%
Soothe And Cool Inzo Barrier
FDA Label NDC 53329-777
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, Lp for the product Soothe And Cool Inzo Barrier (NDC 53329-777). 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 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 protects
- and helps relieve chapped or cracked skin
- minor cuts, scrapes, and burns
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 eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few 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
Inactive Ingredients
Benzethonium Chloride, Cetyl Alcohol, Chloroxylenol, Cholecalciferol, Glyceryl Stearate, Lanolin, Quaternium-15, Retinyl Palmitate, Sodium Cocoyl Isethionate, Sorbitol, Tocopheryl Acetate, Water, Zinc Oxide.
Package/Label Principal Display Panel
Soothe&cool Inzo Barrier Cream (2ea0be6a 3e09 46f7 873e 35d57f4d643e 01)
NDC: 53329-777-04
Soothe & Cool
Protect
INZO Barrier Cream
with 5% dimethicone
Invisible Skin Protectant
Contains Zinc Oxide
Extra-Strength
REF MSC095420
Medline
4 Fl. Oz. (118.29 mL)
* Please review the disclaimer below.
