83490-316 OIASKIN Wrinkle patch

Dimethicone by

Drug Labeling and Warnings

Dimethicone by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIMETHICONE- cyclomethicone patch 
2359 US INC

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.

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83490-316 OIASKIN Wrinkle patch

Active Ingredients

Dimethicone

Purposes

Dimethicone____anti wrinkle

Uses

Oia is here to fix all wrinkle worries! Oia silicone patches gently compress and protect the skin to noticeably minimize the appearance of fine lines and wrinkles. Our patches are the fastest anf safest way to achieve anti-aging effects. You can leave them on while you relax or even while you sleep!

Warnings

Keep out of reach of children and pets.

Warnings

Do not use on open wounds, cuts, irritated, or infection skin. Do not use if you have a sensitivity or allergy to silicone adhesives.

Warnings

If irritation or rash appears.

Warnings

When using this product skin irritation and dryness is more likely to occur if you use
another topical acne medication at the same time. If irritation occurs, only use one
topical acne medication at a time.

Warnings

Other skincare products and sweating may interfere with adhesion of the patches, be sure that your skin is completely dry before applying. For best result, place patches back on the storage sheets and keep inside the pouch in between uses. Handle with care.

For external use only.

Directions

STEP 1- Thoroughly cleanse and dry your skin before usage. Allow skincare to properly absorb prior to patch applisction as excess misture might cause the patches to slide off.

STEP 2- Carefully remove the seal from the patch and position above the desired area. Make sure to streych the surface of your skin as much as possible before application.

STEP 3- After you apply the patch, gently press onto it ti flatten out any air bubbles that may form.

STEP 4- After use, rinse the patches with just water(or with mild soap) and allow the patches to air dry adhesive side up before storing back on the sheet provided.

Inactive Ingredients

Cyclomethicone

Label

DIMETHICONE 
cyclomethicone patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	48 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-316-01	48 g in 1 POUCH; Type 0: Not a Combination Product	06/01/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-316)

Revised: 7/2024

Document Id: 1e636062-82c8-8071-e063-6294a90a16b5

34390-5

Set id: fd0bf578-3e50-d4aa-e053-6394a90a1415

Version: 3

Effective Time: 20240729