hydrocortisone

Uses For the temporary relief associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external genital and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

Purpose Antipruritic (Anti-itch)

Directions 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, consult a doctor For External Anal Itching Users adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product children under 12 years of age: consult a doctor

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Do not use this product and ask a doctor if you have a vaginal discharge before treating diaper rash before using on children under 2 years of age

Stop use and ask a doctor if • condition worsens, or if 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

Stop use and ask a doctor if Condition worsens If 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 you have consulted a doctor. Do no use for diaper rash. Consult a doctor.

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an aproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermitis, allergic contact dermatis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Allegis Holdings, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or https://fda.gov/Safety/MedWatch/

DESCRIPTION Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the molecular formula C 21 H 30 O 5 and is represented by the following structural formula: Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemical structure.png

Active Ingredient Hydrocortisone 1% (Micronized)

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

HOW SUPPLIED Hydrocortisone Lotion USP, 2.5% is available as follow: NDC: 72162-1441-4: 2 fl oz (59 mL) in a BOTTLE NDC: 72162-1441-7: 4 fl oz (118 mL) in a BOTTLE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504