PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE- hydrocortisone cream

PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE by

Drug Labeling and Warnings

PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE by is a Otc medication manufactured, distributed, or labeled by Click Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, oak, or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, temporarily relieves external anal and external genital 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:  In the genital area if you have a vaginal discharge. Consult a doctor. For the treatment of diaper rash. Consult 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  Rectal bleeding occurs Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or 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 immediately.

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: do not use, ask a doctor

For external anal and external genital itching, adults:
When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or 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 20-25°C (68-77°F)

Inactive ingredients:

Aloe barbadensis leaf juice, Cetyl alcohol, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White petrolatum, Xanthan gum.

SPL UNCLASSIFIED SECTION

ULTRA SOOTHING ALOE

Manufactured for: ProHeal
Surfside, FL

www.prohealproducts.com
772-776-4325 (Rev. 08/25)

Packaging

INGREDIENTS AND APPEARANCE

PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86173-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86173-005-04	113 g in 1 JAR; Type 0: Not a Combination Product	08/28/2025
2	NDC: 86173-005-16	454 g in 1 JAR; Type 0: Not a Combination Product	08/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/28/2025

Labeler - Click Industries LLC (117033580)