OTC Medication Information: Skindurance

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.

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 Label
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Back Label
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SKINDURANCE
dimethicone stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69802-025
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
C18-36 ACID TRIGLYCERIDE
TRIBEHENIN
ALOE VERA LEAF
JOJOBA OIL
ALLANTOIN
.ALPHA.-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
HAMAMELIS VIRGINIANA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69802-025-01 7090 mg in 1 APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/01/2015
Labeler — Skindure, LLC (079763592)

Revised: 04/2015 Skindure, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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