TRIPLEPASTE ADULT CARE RASH TREATMENT- zinc oxide paste

TriplePaste Adult Care Rash Treatment by

Drug Labeling and Warnings

TriplePaste Adult Care Rash Treatment by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 undergarments promptly
• Cleanse affected areas and allow skin to dry
• Apply ointment liberally and as often as necessary, with each undergarment change, especially at bedtime or any time when exposure to wetness 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

TRIPLE PASTE ®

Zinc Oxide / Skin Protectant

Adult Care Rash Treatment

Fragrance-free Hypoallergenic

PREVENTS

TREATS
SOOTHES

Net Wt. 8oz. (227g)

INGREDIENTS AND APPEARANCE

TRIPLEPASTE ADULT CARE RASH TREATMENT 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-031
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)
BEESWAX (UNII: 2ZA36H0S2V)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
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: 16864-031-01	227 g in 1 JAR; Type 0: Not a Combination Product	05/15/2021

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)