Otc - Active Ingredient
Allantoin 1% (w/w/)
Tagrid Skin Repair Cream
FDA Label NDC 85384-0007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Tagrid Skin Repair Cream (NDC 85384-0007). 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 - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin protectant
Indications & Usage
Temporarily protects minor cuts, scrapes, and burns. Helps relieve and promote healing of chapped, chafed, or cracked skin.
Warnings
For external use only
Otc - Do Not Use
Do not use: In the eyes, nose, mouth, or on large
areas of the body
If you are allergic to mupirocin or any of the ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if you have:
Deep or puncture wounds
Animal bites
Serious burns
Large areas of damaged skin
Otc - When Using
■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
■ Use only as directed. Do not use for longer than prescribed.
■ Do not bandage tightly unless directed by a doctor.
Otc - Stop Use
Stop use and ask a doctor if
Condition worsens or does not improve within 3-5 days
Rash,irritation, or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Clean the affected area before application.
Apply a small amount of the ointment to the affected area 1 to 3 times daily, or as directed by a
healthcare provider.
May cover with a sterile bandage if desired.
Wash hands after use.
Other Safety Information
Store in a cool, dry place (59-86°F/15-30°C)
Close the cap tightly after use
Otc - Questions
Questions or comments?
Contact us at:
[email protected]
Distributed by TAGRID LLC
San Francisco, CA, USA 94131
Website: tagridstore.com
Inactive Ingredient
Beeswax,
Calendula officinalis Flower Extract,
Cocos nucifera (Coconut) Oil,
Gossypium herbaceum (Cotton) Seed Oil,
Simmondsia chinensis (Jojoba) Seed Oil,
Magnesium Oxide,
Medium Chain Triglycerides,
Mentha piperita
(Peppermint) Oil,
Salvia officinalis (Sage) Oil,
Silver Stearate,
Helianthus annuus (Sunflower) Seed Oil,
Melaleuca alternifolia (Tea Tree) Leaf Oil,
Thuja occidentalis Leaf Extract,
Zinc Oxide.
* Please review the disclaimer below.
