FIFTHPULSE HYDROCORTISONE- hydrocortisone ointment

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For 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 external feminine, genital 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.
• for external genital itching if you have vaginal discharge. consult a doctor.

When using this product

avoid contact with eyes. do not begin the use of any other hydrocortisone product unless you have consult a doctor. for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop using this product and ask a doctor if:

condition worsens  symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years 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.

For external and anal itching

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or blotting with tissue or a soft cloth before application of this product.
• Children under 12 years of age with external anal itching:consult a doctor.

Other information

• Store at controlled room temperature 20° - 25° C (68° - 77° F)
• Close cap tightly after use.

Inactive ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Edetate disodium, Methylparaben, Mineral oil, Mono-and di-glycerides, Petrolatum, Polysorbate 60, Propylene glycol, Propylparaben, Purified water, Sorbitan monostearate.

Questions or Comments?

Please call 1-888-209-5201

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

FIFTHPULSE HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87525-003
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87525-003-01	1 in 1 BOX	04/30/2026
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 87525-003-02	1 in 1 BOX	04/30/2026
2		113.4 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 Drug	M017	04/30/2026

Labeler - WeCare Products LLC (085508446)

Registrant - WeCare Products LLC (085508446)