TRIPLE MEDICATED FOR DIAPER RASH- zinc oxide paste 
Summers Laboratories Inc

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SUMMERS LABS (as PLD) - TRIPLE PASTE (11086-021)

ACTIVE INGREDIENT

ZINC OXIDE 12.8%

PURPOSE

SKIN PROTECTANT

USES

WARNINGS

FOR EXTERNAL USE ONLY

When using this product

Stop and ask a doctor if

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

INACTIVE INGREDIENTS

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

Triple Paste 2 oz_Unit Carton

Triple Paste 8oz label

Triple Paste 16 oz label

TRIPLE  MEDICATED FOR DIAPER RASH
zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11086-021-0156.7 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
2NDC:11086-021-02454 g in 1 JAR; Type 0: Not a Combination Product10/30/2013
3NDC:11086-021-03240 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
4NDC:11086-021-05284 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
5NDC:11086-021-06100 g in 1 PACKAGE; Type 0: Not a Combination Product10/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/30/2013
Labeler - Summers Laboratories Inc (002382612)

Revised: 10/2023
Document Id: 074d1c12-3cb5-292c-e063-6294a90a41f3
Set id: f9fd9395-48bc-43be-a3d9-ec7fcad339a9
Version: 12
Effective Time: 20231009
 
Summers Laboratories Inc