GLYTONE SOOTHE CALMING- hydrocortisone cream 
Genesis Pharmaceutical, 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.

----------

Glytone Soothe Calmining

Active ingredient(s)

Hydrocortisone 1%

Purpose

Anti pruritic(Anti-itch)

Use(s)

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

Warnings

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

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.

Storage

  • Store at room temperature
  • Do not freeze

Inactive ingredients

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

Questions

 1-800-459-8663 www.glytone-usa.com

Principal Display Panel

NDC 64760-093-01 GLYTONE POST OP sooth calming cream 1% HYDROCORTISONE Net Wt. 1 Ox. / 28.3 g

Glytone soothe calming cream

GLYTONE SOOTHE CALMING 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64760-093
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
PETROLATUM 
CETOSTEARYL ALCOHOL 
GLYCERIN 
POLYOXYL 40 STEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-093-011 in 1 CARTON
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/24/201011/30/2013
Labeler - Genesis Pharmaceutical, Inc. (117196928)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Pharmaceutical, Inc.784338563MANUFACTURE(64760-093)

Revised: 7/2014
Document Id: 26a7019c-5985-4943-b84f-3478de2c41cf
Set id: 4337762e-8d09-4722-961c-c624e16c1a20
Version: 8
Effective Time: 20140723
 
Genesis Pharmaceutical, Inc.