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%..................................................................Anti-itch

PURPOSE

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison ivy, oak, sumac
• temporarily relieves external anal and genital 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

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.
• more than directed unless directed by a doctor.
  

WHEN USING

When using this product

• avoid contact with the eyes
• do not put this product into the rectum by using fingers or any mechanical device or applicator.
  

STOP USE

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor
• rectal bleeding occurs
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• for itching of skin irritation, inflammation, and rashes:
• 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: ask a doctor
• Adults: for external anal itching:
• for external anal and genital itching, adults:
• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor
  

STORAGE AND HANDLING

Other information

• Store at room temperature 20°-25°C (68°-77°F)
  

INACTIVE INGREDIENT

Inactive ingredients aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

DOSAGE & ADMINISTRATION

Distributed By:

Productos Zapotol Corp.

Palmdale, CA 93550

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUADRYDERN 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59428-403
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
ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
WHITE WAX (UNII: 7G1J5DA97F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ICODEXTRIN (UNII: 2NX48Z0A9G)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59428-403-57	1 in 1 CARTON	03/11/2020
1		57 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	03/11/2020

Labeler - Productos Zapotol Corp (186063850)