Scar Patch

SCAR PATCH- allantoin, lidocaine and petrolatum patch
Binger Consulting Corporation

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.

Other Ingredients vitamin E, onion extract

Active Ingredient

Allantoin 2.00 %

Lidocaine 5.00 %

Petrolatum 30.00 %

Purpose

Skin Protectant

Topical Anesthetic

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 persist for 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 25 C (77 F). avoid direct sunlight

Questions or comments? call weekdays from 9 AM to 5 PM CST

scar1
(click image for full-size original)

SCAR PATCH
allantoin, lidocaine, petrolatum patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69440-003
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:69440-003-15 15 BOX in 1 BOX contains a BOX (69440-003-02)
1 NDC:69440-003-02 15 PATCH in 1 BOX This package is contained within the BOX (69440-003-15) and contains a PATCH (69440-003-01)
1 NDC:69440-003-01 100 g in 1 PATCH This package is contained within a BOX (69440-003-02) and a BOX (69440-003-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2014 07/31/2016
Labeler — Binger Consulting Corporation (079635976)
Establishment
Name Address ID/FEI Operations
Binger Consulting Corporation 079635976 relabel (69440-003)

Revised: 07/2016 Binger Consulting Corporation

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