Glytone soothe calming

Dosage form: cream
Ingredients: Hydrocortisone .3mL in 30mL
Labeler: Genesis Pharmaceuticals
NDC Code: 64760-093

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-093
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone.3 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
PETROLATUM 
CETOSTEARYL ALCOHOL 
GLYCERIN 
POLYOXYL 40 STEARATE 
Packaging
#Item CodePackage Description
1NDC:64760-093-011 TUBE (TUBE) in 1 BOX
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/2010
Labeler - Genesis Pharmaceuticals (784338563)
Establishment
NameAddressID/FEIOperations
Genesis Pharmaceuticals784338563manufacture(64760-093)

Revised: 07/2012
 
Genesis Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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