SELAN DM DIABETICS INTENSIVE MOISTURIZING- selan dm diabetics intensive moisturizing 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 DM Diabetics Intensive Moisturizing

Active Ingredient

Dimethicone 5%

Purpose

Skin protectant

Uses

helps relieve, prevent and temporarily protect chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens. symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds. animal bites, serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

apply as needed to dry, rough, or problem skin areas. reapply as often as needed

Inactive Ingredients

water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol, phenoxyethanol, hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

SPL Unclassified Section

Distributed by: Span America

Span-America Medical Systems, Inc.

70 Commerce Center,

Greenville, SC 29615 800-888-6752

Package label

Selan Intensive

SELAN DM DIABETICS INTENSIVE MOISTURIZING
selan dm diabetics intensive moisturizing cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0159-7700
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BEHENYL ERUCATE (UNII: 681898L9A8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0159-7700-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/30/2017	07/31/2020

Labeler - Trividia Manufacturing Solutions, Inc (018927392)

Revised: 12/2020

Document Id: b5a9a9e7-8dc2-cc72-e053-2995a90aba2c

Set id: 52044201-27cc-1acc-e054-00144ff8d46c

Version: 3

Effective Time: 20201204

Trividia Manufacturing Solutions, Inc