TRIPLE DIAPER RASH- zinc oxide ointment 
Advantice Health, 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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Triple Paste® Diaper Rash Ointment

Drug Facts

Active ingredient

Zinc oxide 12.8%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

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.

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

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow skin to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any lime exposure to wet diapers may be prolonged

Other information

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

white petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel extract.

Questions?

1-800-345-0032

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PEDIATRICIAN RECOMMENDED

TRIPLE PASTE®
12.8% Zinc Oxide / Skin Protectant

All-in-One

TRIPLE PROTECTION

PREVENTS
stops diaper rash before it starts

TREATS
restores irritated skin to health

SOOTHES
immediate soothing relief for sensitive skin

•Fragrance-free•

Net Wt. 3oz. (85g)

Principal Display Panel - 85 g Tube Carton
TRIPLE DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
STARCH, CORN (UNII: O8232NY3SJ)  
LANOLIN (UNII: 7EV65EAW6H)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LEVOMENOL (UNII: 24WE03BX2T)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
OAT (UNII: Z6J799EAJK)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16864-021-03227 g in 1 JAR; Type 0: Not a Combination Product05/15/2021
2NDC:16864-021-04283 g in 1 JAR; Type 0: Not a Combination Product05/15/2021
3NDC:16864-021-05454 g in 1 JAR; Type 0: Not a Combination Product05/15/2021
4NDC:16864-021-021 in 1 CARTON05/15/2021
485 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:16864-021-011 in 1 CARTON05/15/2021
557 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:16864-021-061 in 1 CARTON05/15/2021
611.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/15/2021
Labeler - Advantice Health, LLC (192527062)

Revised: 9/2022
Document Id: 453e05e8-7571-4d4c-b4d9-676664e55b59
Set id: d457c58d-8239-41c4-999e-d0ba237e3945
Version: 4
Effective Time: 20220906
 
Advantice Health, LLC