PROCURE HYDROCORTISONE PLUS CALENDULA- hydrocortisone cream 
Profoot, Inc.

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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ProCure Hydrocortisone Cream + Calendula

Active ingredients (each gram contains)

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis

  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor.

Warnings

For external use only.

Do not use

  • in the genital area if you have a vaginal discharge. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.

When using this product

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens
  • rectal bleeding occurs
  • 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 asked a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
  • 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

Other information

Store at room temperature.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Butylene Glycol, Calendula Officinalis Flower Extract, Caprylyl Glycol, Ceratonia Siliqua (Carob) Gum, Ceteareth-20, Cetearyl Alcohol, Chondrus Crispus (Carrageenan), Cocos Nucifera (Coconut) Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Isopropyl Myristate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol

Questions or comments?

Call 1-800-526-3668

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PROCURE  HYDROCORTISONE PLUS CALENDULA
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-171
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
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LOCUST BEAN GUM (UNII: V4716MY704)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29784-171-421 in 1 CARTON02/14/201702/01/2022
1NDC:29784-171-4128 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 finalpart34802/14/201702/01/2022
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612manufacture(29784-171)

Revised: 3/2022
 
Profoot, Inc.