Otc - Active Ingredient
Active Ingredients
Allantoin- 0.50%
Dimethicone- 1.50%
Rapid Repair Healing Cream
FDA Label NDC 65278-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Labs Llc for the product Rapid Repair Healing Cream (NDC 65278-110). 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 - when using, otc - ask doctor, otc - do not use, otc - 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
Otc - Purpose
Active Ingredient ...............................Purpose
Allantoin 0.50%...................................Skin protectant
Dimethicone 1.50%............................Skin protectant
Indications & Usage
Uses
- temporarily protects and helps relieve chapped or cracked skin.
- Helps protect from the drying effects of wind and cold weather.
Warnings
Warnings For external use only.
Otc - When Using
When Using this product
- Keep out of the eyes. Rinse with water to remove.
Otc - Ask Doctor
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 - Do Not Use
Do not use on
- deep or puncture wounds
- animal bites
- serious burns
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 as needed
Other Safety Information
Other information:
- Store at 20-25C (68-77F)
Inactive Ingredient
Inactive Ingredients
Water/ Aqua, Stearic acid, Glycerin, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glyceryl Stearate SE, Cetearyl Alcohol, Fragrance/Parfum , Caprylyl Glycol, Squalane, Leontopodium Alpinum Flower/leaf Extract, Xanthan Gum, Linoleic Acid, Lecithin, Caprylhydroxamic Acid, Sodium Hydroxide, Phytosteryl Canola Glycerides, Disodium EDTA, Butyrospermum Parkii (Shea) Butter, Ceramide NP, Argania Spinosa Kernel Oil, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Oleic Acid, Palmitic Acid, Triolein, Tocopherol, Potassium Sorbate, Sodium Benzoate, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Colloidal Oatmeal, Citric Acid,Camellia Sinensis Leaf Extract, Linalool, Amyl Cinnamal, Geraniol, Limonene , Hydroxycitronellal
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