Otc - Active Ingredient
Dimethicone 5%
Water Drench Hyaluronic Healing Balm Cream
FDA Label NDC 54031-581
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peter Thomas Roth Labs, Llc for the product Water Drench Hyaluronic Healing Balm (NDC 54031-581). 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 - 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
Skin protectant
Uses
- Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.
- Helps protect from the drying effects of wind and cold weather.
Indications & Usage
Uses
Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.
Helps protect from the drying effects of wind and cold weather.
Warnings
For external use only
Otc - When Using
- Do not get into eyes
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 - Do Not Use
Do not use on
- deep or pumcture wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away.
Dosage & Administration
Directions
- Apply as needed
- Massage onto the face as the final step of your skin care routine.
- Can also be used as a spot treatment for dry patches anywhere on the body.
Inactive Ingredient
WATER/AQUA/EAU, GLYCERIN, ISOPROPYL MYRISTATE, CETYL ALCOHOL, CETYL PALMITATE, GLYCERYL STEARATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, C10-18 TRIGLYCERIDES, SQUALANE, SODIUM HYALURONATE, PANTHENOL, TOCOPHERYL ACETATE, CITRIC ACID, SODIUM STEAROYL GLUTAMATE, XANTHAN GUM, SODIUM PHYTATE, ETHYLHEXYL PALMITATE, SODIUM BENZOATE, POTASSIUM SORBATE, GLUCOMANNAN, ETHYLHEXYLGLYCERIN, TRIHYDROXYSTEARIN, PHENOXYETHANOL
Otc - Questions
Question or comments?
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