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SKIN SAKE Surface Protectant

Medically reviewed on April 24, 2018.

Dosage form: ointment
Ingredients: DIMETHICONE 2.272g in 113.6g
Labeler: Skin Sake, LLC
NDC Code: 43447-4410

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

Drug Facts

Active Ingredient

Dimethicone 2%

Purpose

Skin Protectant

Keep out of reach of children

Keep out of reach of children.

Uses
  • Helps soothe, treat, and prevent ulcer-prone areas, cracked skin, rashes
  • Repels wetness
  • Protects delicate skin
  • Relieves chapped, moist areas
  • Prevents friction

Warnings

For external use only.

When using this product, do not get into eyes.

Stop 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 punctured wounds, animal bites, serious burns.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse and dry area. Apply liberally as often as necessary, at least 4 or 5 times per day. Re-apply as needed.

Store between 15° -30° C, (59° -86° F)

Inactive ingredients

Aloe Barbadensis Extract, Acidium Boricum, Castor Oil, Cholecalciferol (Vitamin D), Cod Liver Oil, Green 6, Microcrystalline Wax, Mineral Oil, Myroxylon pereirae (Balsam Peru) Resin, Red 17, Vitamin A, Vitamin E, White Petrolatum, White Wax, Yellow 11

Product Label

www.skinsake.com


SKIN SAKE

Surface Protectant

PHARMACIST FORMULATED

Soothes and Prevents:

Ulcer-Prone Areas
Reddened/Cracked Skin
Incontinent Rashes
Chafed Areas

Repels Wetness
Vitamin A, D, E, and Aloe

NET WT 4OZ  SP02

Manufactured for:

Skin Sake

P.O. Box 390

Hamburg, AR 71646

1-888-853-5544

681441-00

SKIN SAKE SURFACE PROTECTANT 
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-4410
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE2.272 g  in 113.6 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BORIC ACID 
CASTOR OIL 
CHOLECALCIFEROL 
COD LIVER OIL 
D&C GREEN NO. 6 
MICROCRYSTALLINE WAX 
MINERAL OIL 
BALSAM PERU 
D&C RED NO. 17 
VITAMIN A 
.ALPHA.-TOCOPHEROL 
PETROLATUM 
WHITE WAX 
D&C YELLOW NO. 11 
Packaging
#Item CodePackage Description
1NDC:43447-4410-0113.6 g in 1 TUBE
2NDC:43447-4410-2100 PACKET (PACKET) in 1 BOX
2NDC:43447-4410-18 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2009
Labeler - Skin Sake, LLC (195912717)
Registrant - Skin Sake, LLC (195912717)
Establishment
NameAddressID/FEIOperations
Memphis Contract Packaging, Inc.185390010manufacture(43447-4410)

 
Skin Sake, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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