TRIPLE DIAPER RASH- zinc oxide ointment

Triple Diaper Rash by

Drug Labeling and Warnings

Triple Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 productdo 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

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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)

INGREDIENTS AND APPEARANCE

TRIPLE DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-021-03	227 g in 1 JAR; Type 0: Not a Combination Product	05/15/2021
2	NDC: 16864-021-04	283 g in 1 JAR; Type 0: Not a Combination Product	05/15/2021
3	NDC: 16864-021-05	454 g in 1 JAR; Type 0: Not a Combination Product	05/15/2021
4	NDC: 16864-021-02	1 in 1 CARTON	05/15/2021
4		85 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 16864-021-01	1 in 1 CARTON	05/15/2021
5		57 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 16864-021-06	1 in 1 CARTON	05/15/2021
6		11.5 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 16864-021-07	6 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/15/2021

Labeler - Advantice Health, LLC (192527062)