SELAN PLUS ZINC OXIDE- selan plus zinc oxide cream 
Trividia Manufacturing Solutions, Inc

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.

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Selan Plus Zinc Oxide

Active Ingredients

Dimethicone 2.1%

Zinc Oxide 2%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information:

Store at room temperature

Purified Water USP, Cetyl Alcohol, Sorbitol USP, Glycerol Monostearate, Sodium Lauryl Sulfate, Lanolin USP, Methylparaben, Fragrance, Propylparaben.

Image of 4oz tube

SelanZinc4ozTube.jpg

Image of 4oz tube artwork

Image of 16oz jar

SelanZinc16ozJar.jpg

Image of 16oz Jar Artwork

Image of 8ml packet

SelanZinc8mlPacket.jpg

Image of Selan Zinc 8mL Packet Artwork

SELAN PLUS ZINC OXIDE 
selan plus zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0159-2200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.1   in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0159-2200-04117 g in 1 TUBE; Type 0: Not a Combination Product08/29/1997
2NDC:0159-2200-018.1 g in 1 PACKET; Type 0: Not a Combination Product08/29/1997
3NDC:0159-2200-17458 g in 1 JAR; Type 0: Not a Combination Product08/29/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/29/1997
Labeler - Trividia Manufacturing Solutions, Inc (018927392)
Establishment
NameAddressID/FEIBusiness Operations
Trividia Manufacturing Solutions, Inc018927392manufacture(0159-2200) , label(0159-2200) , pack(0159-2200)

Revised: 3/2021
Document Id: bd3387ac-3696-1fb0-e053-2a95a90a161f
Set id: 07396c61-1dfd-4be7-bddf-0eb570a18463
Version: 3
Effective Time: 20210310
 
Trividia Manufacturing Solutions, Inc