SOF SKIN BABY PETROLEUM- petrolatum jelly 
Viny Health and Beauty Inc

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

White Petrolatum USP 99.9 %

Purpose

Skin Protectant

Uses

  • Helps to treat and prevent diaper rash.
  • Helps seal out wetness.

Warning

For external use only.

Do not use on

  • Deep or Puncture Wounds
  • Animal Bites
  • Serious Burns

When using this product

  • Do not get in to eyes

Stop use and ask doctor if

  • Condition worsen.
  • Symptoms lasts more than 7 days or clean up and occur again.

Keep out of reach of children

  • Children if swallowed get medical help or contact Poison Control Center right away.

Directions

  • Apply product liberally to clean out diaper rash area.

Inactive Ingredients

Fragrance

Other information

Store at room temperature.

PRINCIPAL DISPLAY PANEL

SOF SKIN BABY PETROLEUM JELLY

NET WT. 6 OZ (170 g)

pertolium jelly label

SOF SKIN BABY PETROLEUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76436-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76436-129-08226 g in 1 JAR; Type 0: Not a Combination Product03/27/200710/26/2017
2NDC:76436-129-06170 g in 1 JAR; Type 0: Not a Combination Product03/27/200710/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/200710/26/2017
Labeler - Viny Health and Beauty Inc (963374942)

Revised: 10/2017
Document Id: 20097813-bd1c-415d-a665-765dd96a0b78
Set id: 6c2b0f2d-ad64-48ce-a4b4-6a33a9b5725c
Version: 7
Effective Time: 20171026
 
Viny Health and Beauty Inc