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Drug Facts
Dimethicone Cream
FDA Label NDC 68599-0213
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Dimethicone (NDC 68599-0213). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Dimethicone 5%
Otc - Purpose
Purpose
Skin Protectant
Indications & Usage
Uses
for the treatment and/or prevention of diaper rash
temporarily protects and helps relieve chapped or cracked skin
Warnings
Warnings
For external use only.
When using this product
- do not get into eyes
- deep or puncture wounds
- animal bites
- serious burns
Do not use on
Otc - Stop Use
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
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
- Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
- Apply cream liberally until entire area is covered
- Apply as needed
Other Safety Information
Store at 40-95°F (4-35°C)
Inactive Ingredient
Inactive Ingredients:
Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,
Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,
Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),
Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,
Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,
Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,
Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,
Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,
Tyrosine, Phenylalanine, Cysteine, Triethanolamine
Otc - Questions
Questions?
Call 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-0213-4
McKesson
Thera
DIMETHICONE BODY SHIELD
Provides mild skin protection against irritation from chapped or cracked skin.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-DS4
* Please review the disclaimer below.
