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NDC 16864-0021-04 Triple Diaper Rash 12.8 g/100g Details

Triple Diaper Rash 12.8 g/100g

Triple Diaper Rash is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Advantice Health, LLC. The primary component is ZINC OXIDE.

Product Information

NDC	16864-0021
Product ID	16864-021_453e05e8-7571-4d4c-b4d9-676664e55b59
Associated GPIs	90971020004277
GCN Sequence Number	062770
GCN Sequence Number Description	zinc oxide OINT. (G) 12.8% TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	98544
HICL Sequence Number	002361
HICL Sequence Number Description	ZINC OXIDE
Brand/Generic	Brand
Proprietary Name	Triple Diaper Rash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	12.8
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Advantice Health, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 16864-0021-04 (16864002104)

Pricing Information	N/A
NDC Package Code	16864-021-04
Billing NDC	16864002104
Package	283 g in 1 JAR (16864-021-04)
Marketing Start Date	2021-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d457c58d-8239-41c4-999e-d0ba237e3945 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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

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

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

Search by Drug Name or NDC

NDC 16864-0021-04 Triple Diaper Rash 12.8 g/100g Details

Triple Diaper Rash 12.8 g/100g

Product Information

Package

Package Images

NDC 16864-0021-04 (16864002104)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d457c58d-8239-41c4-999e-d0ba237e3945 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

INGREDIENTS AND APPEARANCE

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