NU-DERM TOLEREEN- hydrocortisone lotion

NU-DERM Tolereen by

Drug Labeling and Warnings

NU-DERM Tolereen by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., Puretek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Hydrocortisone, 0.5%

Purpose

Anti-itch

Uses

• Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
  • Eczema
  • Psoriasis
  • Insect bites
  • Seborrheic dermatitis
  • Soaps
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Jewelry
  • Cosmetics
  • Detergents
• Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

• For external use only.

Do not use

• In the eyes.
• For the treatment of diaper rash.

When using this product do not begin the use of any other hydrocortisone product.

Stop use and ask a doctor if

• Symptoms last for more than 7 days.
• The condition gets worse.
• Symptoms clear up and come back in a few days.

Keep out of the reach of children.

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

Directions

• Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily.
• Children under 2 years of age, do not use, ask a doctor.

Other information

• Store at room temperature. Protect from freezing and excessive heat.

Inactive ingredients

allantoin, butylparaben, cetyl alcohol, cyclopentasiloxane, glycerin, glyceryl stearate, lactic acid, methylparaben, PEG-100 stearate, propylparaben, purified water, saponins, stearyl alcohol, tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

Dist. by OMP, Inc., Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - 57g Bottle Carton

OBAGI
NU-DERM®

TOLEREEN

ANTI-PRURITIC
LOTION

HYDROCORTISONE
USP, 0.5%

NET WT. 2 OZ. (57g)

INGREDIENTS AND APPEARANCE

NU-DERM TOLEREEN   ANTI-PRURITIC
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALLANTOIN (UNII: 344S277G0Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-112-36	1 in 1 BOX
1		57 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/01/1988

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Puretek Corporation		785961046	MANUFACTURE(62032-112) , LABEL(62032-112) , PACK(62032-112)