CLENZIDERM THERAPEUTIC MOISTURIZER- glycerin cream

CLENZIDERM THERAPEUTIC MOISTURIZER by

Drug Labeling and Warnings

CLENZIDERM THERAPEUTIC MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Glycerin 20%

Purpose

Skin protectant

Uses

• ▪ Temporarily protects and helps relieve chapped or cracked skin.
• ▪ Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

When using this product

• ▪ do not get into eyes.

Stop and ask a doctor if

• ▪ condition worsens
• ▪ symptoms last 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 right away.

Directions

• ▪ Apply as needed.
• ▪ Children under 6 months: ask a doctor.

Other information

• ▪ Store away from heat and direct sunlight.
• ▪ Store at controlled room temperature: 15°C–25°C (59°F–77°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, butylparaben, cetyl dimethicone, corn starch modified, cyclopentasiloxane, dimethicone, dimenthicone/vinyl dimethicone crosspolymer, ethylparaben, isobutylparaben, lauryl PEG/PPG-18/18 methicone, methylparaben, phenoxyethanol, propylparaben, triethanolamine, water

Questions or comments?

1.800.636.7546. Monday-Friday 9a.m.-4p.m. Pacific Time

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

OBAGI®
MEDICAL

CLENZIderm M.D.™

TherapeuticMoisturizer
Glycerin 20%
Skin Protectant

1.7 fl. oz. (50 mL)

INGREDIENTS AND APPEARANCE

CLENZIDERM THERAPEUTIC MOISTURIZER 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-614
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-614-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2007

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-614)