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Drug Facts
Dimethicone Liquid
FDA Label NDC 68599-0212
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 68599-0212). 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 1.75%
Otc - Purpose
Purpose
Skin Protectant
Indications & Usage
Uses
- temporarily protects and helps relieve chapped or cracked skin
- cleanses, moisturizes, and helps protect skin
- it can be used on face, body and perineal area
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
- Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
- No rinsing necessary
- Apply as needed
- Apply a protectant cream as necessary
Other Safety Information
Store at 40-95°F (4-35°C)
Inactive Ingredient
Inactive Ingredients:
Purified Water, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Butylene Glycol, Glyceryl Stearate,
PEG 100 Stearate, Stearic Acid, Cetyl Alcohol, Aleurites Moluccana Seed Oil, Phenoxyethanol, Caprylyl Glycol,
Chlorphenesin, Carthamus Tinctorius (Safflower) Oleosomes, Sodium Hyaluronate, Bisabolol,
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),
Fragrance, Disodium EDTA, Zingiber Officinale (Ginger) Root Extract, Triethanolamine, Lysine, Histidine,
Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine,
Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine
Otc - Questions
Questions?
Call 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-0212-8
Thera
MOISTURIZING BODY CLEANSER
A no-rinse topical cleanser
Single Patient Use
NET CONTENTS 8 fl. oz (237 mL)
MFR # 53-MC8
53-mc8 (53 Mc8)
* Please review the disclaimer below.
