HYDROCORTISONE- hydrocortisone cream
Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti Itch)

Uses

for external genital, feminine and anal itching
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, scrapes
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Consult a doctor:

before use if you have a vaginal discharge (for feminine itching)
for external itching, do not exceed the recommended daily dosage or if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
if bleeding occurs

When using this product:

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

Do not use:

for the treatment of diaper rash
with any other Hydrocortisone product unless you have consulted a doctor
if bleeding occurs

Keep out of reach of children.

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

Directions

for 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
adults for external anal itching when practical, clean, clean 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
children under 12 years of age: for external itching, consult a doctor

Other information

store at room temperature 15°-30°C (59°-86°F)
Tamper Evident. Do not use if packet is torn, cut or opened
Avoid excessive heat and humidity

Inactive ingredient

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

Questions or Comments?

1-800-869-6970

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 20 unit Box

Hydrocortisone
cream 1%

0.9 Gram 20 Single Dose Packets
Distributed by Green Guard®, St. Louis, Missouri 63045

PRINCIPAL DISPLAY PANEL – packet

Hydrocortisone
cream 1%

1% Hydrocortisone

Anti-itch cream

Dist by GREEN GUARD

Net Wt. 0.9g

First Aid and Safety Service St. Louis, MO 63045

HYDROCORTISONE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:47682-397
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone (Hydrocortisone)	Hydrocortisone	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
alcohol
methylparaben
mineral oil
paraffin
petrolatum
propylparaben
water
white wax

#	Item Code	Package Description
Packaging
1	NDC:47682-397-71	20 in 1 BOX
1	NDC:47682-397-99	0.9 g in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2013

Labeler - Unifirst First Aid Corporation (832947092)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(47682-397)

Revised: 3/2014

Document Id: 88020672-5552-47ef-bf1e-1ff02d8023c2

Set id: 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28

Version: 1

Effective Time: 20140303

Unifirst First Aid Corporation