SCAR GEL ADVANCED FORMULA- allantoin cream

Scar Gel by

Drug Labeling and Warnings

Scar Gel by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Use

Temporarily protects minor:

• cuts
• scrapes
• burns

Temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only.

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into 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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• apply as needed

Other information

• store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

alcohol denatured, allium cepa (onion) bulb extract, carbomer, fragrance, hydrolized collagen, methylparaben, panthenol, PEG-8, purified water, sodium hyaluronate, sodium hydroxide, sorbic acid

Questions or comments?

1-866-323-0107 or visit www.natureplex .com

PRINCIPAL DISPLAY PANEL - 35 g Tube Box

ADVANCED FORMULA

Natureplex™

ScarGel
With
Allantoin
Specially Formulated For Scars

Helps Soften & Smooth
The Appearance Of Scars

NET WT. 1.25 Oz.(35g)

INGREDIENTS AND APPEARANCE

SCAR GEL   ADVANCED FORMULA
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.005 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
COLLAGEN ALPHA-1(III) (HUMAN) (UNII: 5D8UAE62VB)
METHYLPARABEN (UNII: A2I8C7HI9T)
ONION (UNII: 492225Q21H)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-027-01	1 in 1 BOX	11/01/2013
1		35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/01/2013

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-027)