Otc - Active Ingredient
Active ingredient
Dimethicone 5.0%
Sure Result Sr Renew
FDA Label NDC 69837-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Brand Management, Llc for the product Sure Result Sr Renew (NDC 69837-410). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Indications & Usage
Uses
-temporarily protects and help relieve chapped or cracked skin
Warnings
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
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 cream liberally as needed.
Storage And Handling
Other information
-protect from freezing avoid excessive heat
Inactive Ingredient
Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel)
Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl
Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl
Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,
PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,
Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl
Acetate (Vitamin E).
Package Label.Principal Display Panel
Image Description (Dimethicone 410)
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