PREMIUM SCAR PATCH- allantoin, lidocaine, petrolatum patch

Premium Scar Patch by

Drug Labeling and Warnings

Premium Scar Patch by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Active Ingredient

Allantoin 2.00 %

Lidocaine 4.00 %

Pterolatum 30.00 %

DESCRIPTION

Purpose

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

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

Petrolatum 30.00 %..... Skin Protectant

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

DESCRIPTION

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

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

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM SCAR PATCH 
allantoin, lidocaine, petrolatum patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69512-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ONION (UNII: 492225Q21H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-020-01	15 in 1 BOX
1		15 g in 1 PATCH; Type 0: Not a Combination Product

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)