PREMIUM SCAR PATCH - allantoin, lidocaine, 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.

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Drug Facts

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

PREMIUM SCAR PATCH 
allantoin, lidocaine, petrolatum patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69512-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ONION (UNII: 492225Q21H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69512-020-0115 in 1 BOX
115 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/15/2015
Labeler - Alivio Medical Products, LLC (079670828)

Revised: 4/2015
Document Id: 8ebdaa79-4eb9-4e26-8545-941e8032d713
Set id: c3f3e86f-0def-4fd9-96dd-22931d78081c
Version: 3
Effective Time: 20150413
 
Alivio Medical Products, LLC