TRIPLE MEDICATED FOR DIAPER RASH- zinc oxide paste

TRIPLE by

Drug Labeling and Warnings

TRIPLE by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

When using this product

• DO NOT GET INTO EYES

STOP USE

Stop and ask a doctor if

• condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT 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 time exposure to wet diapers may be prolonged

INACTIVE INGREDIENTS

white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE  MEDICATED FOR DIAPER RASH
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
STARCH, CORN (UNII: O8232NY3SJ)
LANOLIN (UNII: 7EV65EAW6H)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
YELLOW WAX (UNII: 2ZA36H0S2V)	8 g  in 100 g
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-021-01	56.7 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2013
2	NDC: 11086-021-02	454 g in 1 JAR; Type 0: Not a Combination Product	10/30/2013
3	NDC: 11086-021-03	240 g in 1 PACKAGE; Type 0: Not a Combination Product	10/30/2013
4	NDC: 11086-021-05	284 g in 1 PACKAGE; Type 0: Not a Combination Product	10/30/2013
5	NDC: 11086-021-06	100 g in 1 PACKAGE; Type 0: Not a Combination Product	10/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/30/2013

Labeler - Summers Laboratories Inc (002382612)

Establishment
Name	Address	ID/FEI	Business Operations
Summers Laboratories Inc		002382612	manufacture(11086-021) , pack(11086-021)