GLYTONE SOOTHE CALMING - hydrocortisone cream
Genesis Pharmaceuticals

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.

----------

Soothe calming

Inactive Ingredients

Water (Aqua), Propylene glycol, Petrolatum, Cetearly Alcohol, Glycerin, PEg-40 Stearate.

Active Ingredients Purpose

Hydrocortisone 1% Anti pruritic(Anti-itch)

Warnings For external use only. Do not apply to wounds or broken skin.

When using this product

Keep out of eyes. Rinse with water to remove.

Do not use for the treatment of diaper rash, consult a doctor.

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For temporary relief of itching associated with minor skin irritation and rashes. Other uses of this product should be only under the advice and supervision of a doctor.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Do not use, consult a doctor.

Other Information

Store at room temperature

Do not freeze.

Glytone

Post Op

Soothe

Calming Cream

1% hydrocortisone

NET WT. 1 Oz. (28 g)

Distributed by Genesis Pharmaceutical Inc. Parsippany, NJ 07054

www.glytone-usa.com

1-800-459-6663

Made in USA

Purpose Antipruritic (anti-itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

GLYTONE SOOTHE CALMING
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:64760-093
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone (Hydrocortisone)	Hydrocortisone	.3 mL in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
PROPYLENE GLYCOL
PETROLATUM
CETOSTEARYL ALCOHOL
GLYCERIN
POLYOXYL 40 STEARATE

#	Item Code	Package Description
Packaging
1	NDC:64760-093-01	1 in 1 BOX
1		30 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/24/2010

Labeler - Genesis Pharmaceuticals (784338563)

Name	Address	ID/FEI	Business Operations
Establishment
Genesis Pharmaceuticals		784338563	manufacture(64760-093)

Revised: 7/2012

Document Id: 600c905e-5826-4499-ab27-089d19f0488c

Set id: 4337762e-8d09-4722-961c-c624e16c1a20

Version: 3

Effective Time: 20120719

Genesis Pharmaceuticals