DIAPER RASH SKIN PROTECTANT- lanolin and petrolatum ointment 
Universal Distribution Centre 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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Diaper Rash Ointment

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

Active ingredientsPurpose
Lanolin 15.5%Diaper rash ointment
Petrolatum 53.4%Skin Protectant

Uses

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
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store between 20°C to 25 °C (68° to 77°F)

Inactive Ingredients

cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

PRINCIPAL DISPLAY PANEL - 35.4g Carton

Label

DIAPER RASH SKIN PROTECTANT 
lanolin and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN136.4 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM469.9 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Product Characteristics
Colororange (Unctuous amber mass) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-073-021 in 1 CARTON01/25/2021
1NDC:52000-073-0135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/25/2021
Labeler - Universal Distribution Centre LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceutical Pvt. Ltd916837425manufacture(52000-073)

Revised: 2/2022
Document Id: d8877f9a-fdf0-e708-e053-2a95a90a315d
Set id: b9bbc5ac-18a9-99ec-e053-2995a90a9a76
Version: 3
Effective Time: 20220221
 
Universal Distribution Centre LLC