Otc - Active Ingredient
Active ingredient
Dimethicone 1.3%
Xtracare Oatmeal Daily Moisturizing Lotion
FDA Label NDC 57337-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Inc. for the product Xtracare Oatmeal Daily Moisturizing (NDC 57337-139). 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 - do not use, otc - stop 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
Purpose
Skin Protectant
Indications & Usage
Uses
- Help prevent and temporarily protects chafed, chapped, or cracked skin.
Warnings
Warnings
For external use only
Otc - When Using
When using this product avoid contact with eyes. In case of eye contact, flush with water.
Otc - Do Not Use
Do not use on
- deep or puncture wounds
- animal bites
- serious burns
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 immediately.
Dosage & Administration
Directions apply liberally as often as needed.
Storage And Handling
Other information Store at room temperature.
Inactive Ingredient
Water, Petrolatum, Isopropyl Myristate, Glycerin, Glyceryl Stearate, Propylene Glycol, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Avena Sativa (Oat) Kernel Extract, Fragrance, DMDM Hydantoin, Stearyl Alcohol, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Methylparaben, Propylparaben.
Otc - Questions
Questions/comments? 1-855-345-5575
* Please review the disclaimer below.
