Label: SKIN SAKE SURFACE PROTECTANT- dimethicone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 43447-4410-0, 43447-4410-1, 43447-4410-2 - Packager: Skin Sake, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 24, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of reach of children
- Uses
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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
- Inactive ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
SKIN SAKE SURFACE PROTECTANT
dimethicone ointmentProduct 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)