PROCURE HYDROCORTISONE PLUS CALENDULA- hydrocortisone cream

ProCure by

Drug Labeling and Warnings

ProCure by is a Otc medication manufactured, distributed, or labeled by Profoot, Inc., Concept Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

PRINCIPAL DISPLAY PANEL

Maximum Strength

HYDROCORTISONE + CALENDULA

NO Parabens

NO Petrolatum

NO Alcohol

ORGANIC Calendula

ORGANIC Coconut Oil

ORGANIC Olive Oil

1% HYDROCORTISONE ANTI-ITCH CREAM

Net wt 1oz (28 g)

INGREDIENTS AND APPEARANCE

PROCURE  HYDROCORTISONE PLUS CALENDULA
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-171
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-171-42	1 in 1 CARTON	02/14/2017
1	NDC: 29784-171-41	28 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	02/14/2017

Labeler - Profoot, Inc. (107570900)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	manufacture(29784-171)