Quadrydern cream

Otc - active ingredient section

Active ingredient Purpose

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

Otc - purpose section

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 section

Warnings For external use only

Otc - do not use section

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

Otc - ask doctor section

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

Otc - when using section

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.

Otc - stop use section

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.

Otc - keep out of reach of children section

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

Indications & usage section

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 section

Other information

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

Inactive ingredient section

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

Dosage & administration section

Distributed By:

Productos Zapotol Corp.

Van Nuys, CA 91402

Made in Korea

Ingredients and appearance - Product information

Quadrydern cream- Hydrocortisone

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 10 mgin 1 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Productos Zapotol Corp( 186063850)

Package label.principal display panel