SKIN SAKE - petrolatum ointment 
Skin Sake, 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.

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Active Ingredient

Drug Facts

Active Ingredient

White Petrolatum

Purpose

Soothes, Treats, Prevents,

Skin Irritations
Chafed Areas
Incontinent Rashes
Pressure Sores


Keep out of reach of children

Keep out of reach of children.

Uses

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 puncture wounds, animal bites, serious burns.

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

Directions



Cleanse and dry area.Apply a thin layer to skin as often as necessary.
Store between 15° - 30° C, (59° - 86° F)

Inactive ingredients

Peruvian Balsam, Aloe, Acidum Boricum, Vitamin E (Tocopherol), Zinc Oxide,  Mineral Oil, Castor Oil, White Beeswax.

Product Label

NDC # 43447-2071-1
SKIN®Sake ointment

Soothes, Treats, Prevents
Skin Irritations
Chafed Areas
Incontinence Rashes
Pressure Sores

Skin Protectant
Moisture Barrier
Aloe and Vit. E Added
with Natural Peruvian Balsam

Net Wt 2.5 oz (71g)

Manufactured by:
SKIN SAKE, LLC
P.O. Box 390, Hamburg, AT 71646

1-888-853-5544  skinsake.com

SS SkinSake Label

SKIN SAKE 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-2071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM23 g  in 71 g
Inactive Ingredients
Ingredient NameStrength
BALSAM PERU (UNII: 8P5F881OCY)  
ALOE (UNII: V5VD430YW9)  
BORIC ACID (UNII: R57ZHV85D4)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
MINERAL OIL (UNII: T5L8T28FGP)  
CASTOR OIL (UNII: D5340Y2I9G)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43447-2071-171 g in 1 TUBE
2NDC:43447-2071-0100 in 1 BOX
2NDC:43447-2071-22 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/01/2005
Labeler - Skin Sake, LLC (195912717)
Registrant - Skin Sake, LLC (195912717)
Establishment
NameAddressID/FEIBusiness Operations
Memphis Contract Packaging, Inc.185390010manufacture(43447-2071)

Revised: 4/2013
Document Id: 85994524-8b8e-489b-94ae-8c4ca6f02a10
Set id: e7ee429a-dc0d-47cc-98f8-0035948fed0a
Version: 1
Effective Time: 20130424
 
Skin Sake, LLC