SKIN SAKE SURFACE PROTECTANT- dimethicone ointment

SKIN SAKE Surface Protectant by

Drug Labeling and Warnings

SKIN SAKE Surface Protectant by is a Otc medication manufactured, distributed, or labeled by Skin Sake, LLC, Memphis Contract Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SKIN SAKE SURFACE PROTECTANT 
dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43447-4410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.272 g  in 113.6 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORIC ACID (UNII: R57ZHV85D4)
CASTOR OIL (UNII: D5340Y2I9G)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
COD LIVER OIL (UNII: BBL281NWFG)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
BALSAM PERU (UNII: 8P5F881OCY)
D&C RED NO. 17 (UNII: ND733RX3JN)
VITAMIN A (UNII: 81G40H8B0T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43447-4410-0	113.6 g in 1 TUBE
2	NDC: 43447-4410-2	100 in 1 BOX
2	NDC: 43447-4410-1	8 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2009

Labeler - Skin Sake, LLC (195912717)

Registrant - Skin Sake, LLC (195912717)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging, Inc.		185390010	manufacture(43447-4410)