QUADRYDERN- hydrocortisone cream 
Productos Zapotol Corp

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.

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Quadrydern N.F. Hydrocortisone Cream 2oz (140, 2019)

Active ingredient                                                                        Purpose

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

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 For external use only

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

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

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 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 the 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.
  • 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

Other information

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

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

Distributed By:

Productos Zapotol Corp.

Van Nuys, CA 91402

Made in Korea

140

QUADRYDERN 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59428-000-561 in 1 CARTON06/30/2013
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/201312/15/2020
Labeler - Productos Zapotol Corp (186063850)

Revised: 12/2021
 
Productos Zapotol Corp