SCAR GEL  ADVANCED FORMULA- allantoin cream 
Natureplex LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Scar Gel
Advanced Formula

Drug Facts

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Use

Temporarily protects minor:

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

Other information

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)

PRINCIPAL DISPLAY PANEL - 35 g Tube Box
SCAR GEL   ADVANCED FORMULA
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.005 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-027-011 in 1 BOX11/01/2013
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2013
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-027)

Revised: 5/2018
Document Id: eee2cb5c-542f-4d10-bebc-8101221429ec
Set id: 980f23bc-6f55-4723-a42d-e282a3507ec0
Version: 3
Effective Time: 20180511
 
Natureplex LLC