AMORAY CARE PETROLEUM BABY- petrolatum jelly 
MY IMPORT USA 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 TREAT AND PREVENT DIAPER RASH.
  • HELPS SEAL OUT WETNESS.

Warnings

For external use only.

Do not use on

  • deep or puncture wounds
  • ANIMAL BITES
  • SERIOUS BURNS

Keep Out of Reach of Children

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

Directions

Apply liberally to clean out diaper rash area.

Inactive Ingredients

None

Stop use and ask doctor if

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

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES.

Baby Pet Jelly 6 Oz 51628-1004-1

Baby Pet Jelly 13 Oz 51628-1004-2

AMORAY CARE PETROLEUM  BABY
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-1004-1170 g in 1 JAR; Type 0: Not a Combination Product03/26/201502/10/2017
2NDC:51628-1004-2369 g in 1 JAR; Type 0: Not a Combination Product03/26/201502/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/26/201502/10/2017
Labeler - MY IMPORT USA INC (195767988)

Revised: 2/2017
Document Id: f7aa0232-3b98-4016-8cdc-73939708eeeb
Set id: db4f0b9c-c5c2-4a95-ab8d-a210e6342b2f
Version: 3
Effective Time: 20170211
 
MY IMPORT USA INC