FDA Label for Premium Scar Patch

View Indications, Usage & Precautions

Premium Scar Patch Product Label

The following document was submitted to the FDA by the labeler of this product Alivio Medical Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Active Ingredient

Allantoin 2.00 %

Lidocaine 4.00 %

Pterolatum 30.00 %

Purpose

Allantoin 2.00 %  ........ Skin Protectant

Lidocaine 4.00 % ........ Topical Anesthetic

Petrolatum 30.00 %..... Skin Protectant

Keep out of reach of children. If pregnant or breastfeeding, contact physician prior to use

Questions or comments? call weekdays from 9 AM to 5 PM CST 800-914-7435


Indications & Usage



Uses

- Scar Management    - Temporarily protects minor cuts, scrapes and burns

-Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations


Warnings



Warnings

For external use only

Do not use

-on deep or puncture wounds, animal bites, serious burns

-in large quantities, particularly over raw surfaces or blistered areas

When using this product

-avoid contact with eyes

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


Dosage & Administration



Directions:

How to apply - clean and dry affected area  -remove mesh from backing and apply to affected area

-use only one mesh at a time, and maximum of four mesh/day  -leave mesh on affected area for up to

8 hours  -do not use mesh for longer than 5 consecutive days  -children under 12 should consult

physician prior to use


Storage And Handling



Other Information: store below 25C (77F), avoid direct sunlight


Package Label.Principal Display Panel




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