Triple Diaper Rash: Package Insert and Label Information

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.

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^®
Zinc Oxide Diaper Rash Cream

TREATS AND PREVENTS
DIAPER RASH

Hypoallergenic

Fragrance-free

Net Wt. 3 oz. (85 g)

TRIPLE DIAPER RASH zinc oxide ointment

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

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

Inactive Ingredients Ingredient Name Strength WHITE PETROLATUM STARCH, CORN LANOLIN STEARYL ALCOHOL YELLOW WAX LEVOMENOL CHOLESTEROL WATER GLYCERIN OAT

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16864-021-03 227 g in 1 JAR None 2 NDC:16864-021-04 283 g in 1 JAR None 3 NDC:16864-021-05 454 g in 1 JAR None 4 NDC:16864-021-02 1 TUBE in 1 CARTON contains a TUBE 4 85 g in 1 TUBE This package is contained within the CARTON (16864-021-02) 5 NDC:16864-021-01 1 TUBE in 1 CARTON contains a TUBE 5 57 g in 1 TUBE This package is contained within the CARTON (16864-021-01) 6 NDC:16864-021-06 1 TUBE in 1 CARTON contains a TUBE 6 11.5 g in 1 TUBE This package is contained within the CARTON (16864-021-06)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 05/15/2021

Labeler — Advantice Health, LLC (192527062)

Revised: 09/2021 Advantice Health, LLC