SELAN PLUS ZINC- selan plus zinc lotion
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 2.3%

Zinc Oxide 2%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chafed skin or minor skin irritation due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

Condition worsens or does not improve within 7 days

Keep out of reach of children

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

Directions

apply cream liberally as often as necessary
change wet and soiled diapers promptly
cleanse the diaper area, and allow to dry
apply cream with each diaper change, especially at bedtime or anytime when exposure to set diapers may be prolonged

Other Information:

Store at room temperature

Inactive ingredients:

Purified Water USP, Cetyl Alcohol, Sorbitol USP, Glycerol Monostearate, Sodium Lauryl Sulfate, Lanolin USP, Methylparaben, Fragrance, Quaternium-15, Propylparaben

Selan plus Zinc Lotion

selan label

SELAN PLUS ZINC
selan plus zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0159-2400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.3 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITOL (UNII: 506T60A25R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
QUATERNIUM-15 (UNII: E40U03LEM0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0159-2400-24	227 g in 1 BOTTLE; Type 0: Not a Combination Product	08/29/1997	11/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/29/1997	11/15/2018

Labeler - Trividia Manufacturing Solutions, Inc (018927392)

Name	Address	ID/FEI	Business Operations
Establishment
Trividia Manufacturing Solutions, Inc		018927392	manufacture(0159-2400) , pack(0159-2400) , label(0159-2400)

Revised: 11/2018

Document Id: 7abc2154-fe18-5c55-e053-2991aa0aaaa1

Set id: 21b5eb54-bc1e-4613-9c06-abd5ee5b6636

Version: 6

Effective Time: 20181115

Trividia Manufacturing Solutions, Inc