Otc - Active Ingredient
Colloidal oatmeal 10.67%
Zinc oxide 3.20%
Dermedial Anti-itch Ointment
FDA Label NDC 70983-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc for the product Dermedial Anti-itch (NDC 70983-029). 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 - ask doctor, 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 ointment
Indications & Usage
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 only.When using this product, avoid contact with the eyes. If condition worsens or does not improve within 7 days, consult a doctor. Keep out of reach of children.
Otc - When Using
Avoid contact with the eyes.
Otc - Ask Doctor
If condition worsens or does not improve within 7 days, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Adults and children 2 years and older: Apply to affected area as needed.
Inactive Ingredient
helianthus annuus (sunflower) seed wax, juniperus virginiana (virginiana cedar) wood oil, lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil, melaleuca ericifolia (rosalina) leaf oil, olea europaea (olive) fruit oil, pelargonium graveolens (rose geranium) flower oil, piper nigrum (pepper) fruit oil, pogostemon cablin (patchouli) leaf oil.
Other Safety Information
Important: For each product, read all product information on outer and inner box flap before using. Keep this package for full information.
Do not use if security seal is broken or missing.
Description
Dermedial Anti-Itch+
calming oat stick
Otc - Questions
Distributed by: Saje Natural Wellness 101-19347 24th Ave Surrey, BC V3S 3S9 | saje.com | @sajewellness | Questions? call 1-877-275-7253 | Made in Canada | Please recycle where possible | SKU 713803
Package Label.Principal Display Panel
topical balm 0.45 oz | 13 g
* Please review the disclaimer below.
