SKINDURANCE- dimethicone stick 
Skindure, 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.

----------

Skindurance

Active Ingredient

Dimethicone (1%)

Purpose

Skin Protectant

Uses

• Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.

• Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only.  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.  Do not use on • deep or puncture wounds • animal bites • serious burns.

Keep out of reach of children.

Directions

• Apply as needed

Inactive Ingredients

Caprylic/Capric Triglycerides, C18-36 Acid Triglycerides, Tribehenin, Aloe Barbadensis Leaf Extract, Jojoba Wax, Allantoin, Tocopheryl Acetate, Retinyl Palmitate, Hamamelis Virginiana (Witch Haxel) Leaf Extract

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call 301-247-9677

Front LabelBack Label

SKINDURANCE 
dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69802-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
JOJOBA OIL (UNII: 724GKU717M)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69802-025-017090 mg in 1 APPLICATOR; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2015
Labeler - Skindure, LLC (079763592)

Revised: 4/2015
Document Id: 53f7aeff-0fb1-4b4a-8c18-06f0a77e12aa
Set id: e802d881-4522-4879-b6c4-e127c8e625d0
Version: 1
Effective Time: 20150430
 
Skindure, LLC