QUADRYDERN- hydrocortisone cream

Quadrydern by

Drug Labeling and Warnings

Quadrydern by is a Otc medication manufactured, distributed, or labeled by Productos Zapotol Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                        Purpose

Hydrocortisone 1%..................................................Antipruritic (Anti-itch)

PURPOSE

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
• for external genital, feminine and anal itching
• other uses of this product should be only under the advice and supervision of a doctor
  

WARNINGS

Warnings For external use only

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if you have a vaginal discharge (for external feminine itching)

WHEN USING

When using this product

• avoid contact with the eyes
• for external anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
• do not put this product into rectum by using finger or any mechanical device or applicator.
  

STOP USE

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up 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

Keep Out of the Reach Of Children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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.
• Adults: for external anal itching:
• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with and appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• children under 12 years of age: for external anal itching, consult a doctor
  

STORAGE AND HANDLING

Other information

• Store at room temperature 15°-30°C (59°-86°F)
  

INACTIVE INGREDIENT

Inactive ingredients aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

DOSAGE & ADMINISTRATION

Distributed By:

Productos Zapotol Corp.

Van Nuys, CA 91402

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUADRYDERN 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59428-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59428-000-56	1 in 1 CARTON	06/30/2013
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2013

Labeler - Productos Zapotol Corp (186063850)