FDA Label for Hydrocortisone

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
ASK A DOCTOR BEFORE USE:
WHEN USING THIS PRODUCT
DO NOT USE
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product B8 Sales, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

for the 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 and scrapes
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
not for external genital, feminine and anal itching

Ask A Doctor Before Use:

for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When Using This Product

avoid contact with eyes
do not put this product into rectum or vagina by using fingers or any mechanical device or applicator

Do Not Use

with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching

KEEP OUT OF REACH OF CHILDREN.

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

Directions

for adults and children 2 years of age and older apply
to affected area 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Other Information

store at room temperature (do not freeze)
do not use any opened or torn packets

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Manufactured for: B8 SALES

Cincinnati,Ohio 45215

Principal Display Panel

1% Hydrocortisone Cream – Carton Label

PIO Put it on®

_1%Hydrocortisone Cream™