Drug Facts
Colloidal Oatmeal 5%
Zaxs Original Bug Bite And Itch
FDA Label NDC 82186-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zax Healthcare Inc. for the product Zaxs Original Bug Bite And Itch (NDC 82186-155). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of the reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Colloidal Oatmeal 5%
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, and insect bites.
Warnings
•For external use only.
•When using this product do not get into eyes or mucous membranes. If this occurs, rinse thoroughly with water.
•If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
•Stop use if:
•irritation develops.
•If you are allergic to any ingredient in this product.
•If hypersensitivity occurs consult a doctor
Keep Out Of The Reach Of Children
Keep out of the reach of children. If swallowed, consult a Poison Control Centre immediately.
Directions
•Apply as needed.
•As soon as bug bite itching occurs.
Inactive Ingredients
Alcohol
Arnica Montana Flower Extract
Caprylic/Capric Glycerides
Caprylyl Glycol
Ceteareth-20
Cetearyl Alcohol
Cetyl Alcohol
Citric Acid
Cocos Nucifera (Coconut) Oil
Glycerin
Glyceryl Stearate
Glycine Soja (Soybean) Oil
Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Menthol
Phenoxyethanol
Sorbic Acid
Tocopherol
Water
Xanthum Gum
Other Information
Store at room temperature.
* Please review the disclaimer below.
