FOTE SPACOLOGY SKIN PROTECTANT- white petrolatum jelly 
FRUIT OF THE EARTH, 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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FOTE SPACOLOGY PETROLEUM JELLY 100% PURE

Active ingredient

White Petrolatum (100%)

Purpose

Skin protectant (ointment)

Uses

• cuts

• scrapes

• burns

Warnings

For external use only

When using this product 

• do not get into eyes

Stop use 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 puncture wounds • animal bites • seriuos burns

Keep out of reach of children.

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

Directions

Apply as needed.

Other information

Label

FOTE SPACOLOGY PETROLEUM JELLY 100% PURE

7.5 OZ (212g)

NDC 62217-046-59

LabelFrontLabelBack1LabelBack2LabelBack3

FOTE SPACOLOGY SKIN PROTECTANT 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-046-59212 g in 1 JAR; Type 0: Not a Combination Product02/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/27/2018
Labeler - FRUIT OF THE EARTH, INC. (079559467)

Revised: 10/2022
Document Id: ec584fe2-1c86-6ffd-e053-2995a90a379a
Set id: f7e8da33-a75b-44d5-af91-31617121690e
Version: 4
Effective Time: 20221031
 
FRUIT OF THE EARTH, INC.