Active Ingredients
Colloidal Oatmeal 2.0%
Calming Itch And Irritation Lotion
FDA Label NDC 54136-183
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Planet Brands Llc for the product Calming Itch And Irritation (NDC 54136-183). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
temporarily protects and helps relieve minor skin irritation and itching due to: rashes
• eczema
poison ivy, oak, or sumac
• insect bites
Warnings
For external use
When Using This Product
Do not get into eyes
Stop Use And Ask Doctor If
Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed.
Other Information
Remove quality seal.
Do not use if quality seal is broken. Store at room temperature.
Inactive Ingredients
WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.
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