Otc - Active Ingredient
Colloidal Oatmeal 2%
Rejuvaskin Eczema Body Wash Liquid
FDA Label NDC 84375-103
11 label sections · Submitted to the FDA by Atlantic Medical Products, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Medical Products, Llc for the product Rejuvaskin Eczema Body Wash (NDC 84375-103). 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 - 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 - Purpose
Skin Protectant
Indications & Usage
Temporarily protects and helps relieve minor skin irritation and itching due to
- rashes
- eczema
Warnings
For external use only
Otc - When Using
Do not get into eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms last more than seven 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 product is swallowed, get medical help or contact a poison control center right away.
Dosage & Administration
Directions. Shake well before use. Gently massage onto wet skin to cleanse. Rinse with luke-warm water and pat skin dry.
Storage And Handling
- Protect the product in this container from excessive heat and direct sun.
- Store below 27° C or 80.6° F
Inactive Ingredient
Calcium Gluconate
Caprylhydroxamic Acid
Caprylyl Glycol
Citric Acid
Cocamidopropyl Hydroxysultaine
Coco-Glucoside
D-Glucono-1,5-lactone
Ethylhexylglycerin
Glycerin
Glyceryl Oleate
Hydrogenated Palm Glycerides Citrate
Lauryl Glucoside
Potassium Sorbate
Propanediol
Sodium Benzoate
Sodium Cocoyl Glycinate
Sodium Hydroxide
Sodium Hypochlorite
Sodium Lauramphoacetate
Sodium Methyl Cocoyl Taurate
Tetrasodium Glutamate Diacetate
Tocopherol
Water
Otc - Questions
Call 727-535-0022
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