GLYTONE SOOTHE CALMING  - hydrocortisone cream 
Genesis Pharmaceuticals

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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

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

30 mL E/ NET WT. 1 Oz. (28 g)

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 NDC Product Code (Source) 64760-093 Route of Administration TOPICAL DEA Schedule

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

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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64760-093-01 1 TUBE In 1 BOX contains a TUBE 1 30 mL In 1 TUBE This package is contained within the BOX (64760-093-01)

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

Labeler - Genesis Pharmaceuticals (117196928)

Revised: 02/2011Genesis Pharmaceuticals