Premium Scar Patch

PREMIUM SCAR PATCH — allantoin, lidocaine and petrolatum patch
Alivio Medical Products, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Uses

– Scar Management — Temporarily protects minor cuts, scrapes and burns

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

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

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

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

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

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

copy of label
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PREMIUM SCAR PATCH
allantoin, lidocaine, petrolatum patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN (ALLANTOIN) ALLANTOIN 2 g in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 5 g in 100 g
PETROLATUM (PETROLATUM) PETROLATUM 30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
ONION
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69512-020-01 15 PATCH in 1 BOX contains a PATCH
1 15 g in 1 PATCH This package is contained within the BOX (69512-020-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/15/2015
Labeler — Alivio Medical Products, LLC (079670828)

Revised: 04/2015 Alivio Medical Products, LLC

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