Hydrocortisone: Package Insert and Label Information

HYDROCORTISONE- hydrocortisone cream
ADVANCED FIRST AID, INC.

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.

ACTIVE INGREDIENT (in each gram)- Hydrocortisone USP 10mg

Antipruritic (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

• for external genital, feminine 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: • before use if you have a vaginal discharge (for external feminine itching)

• 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 by using

fingers or any mechanical device or applicator

Do Not Use: • with any other Hydrocortisone product unless you have consulted a doctor.

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 1 to 2 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. • Children under 12 years of age: for external anal itching,

consult a doctor.

Inactive Ingredients:

citric acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbate 80, propylene glycol, propyl

paraben, purified water, sodium citrate and titanium dioxide.

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HYDROCORTISONE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-370
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
WATER
GLYCERYL MONOSTEARATE
GLYCERIN
PETROLATUM
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67060-370-39 25 PACKET in 1 CARTON contains a PACKET (67060-370-09)
1 NDC:67060-370-09 0.9 g in 1 PACKET This package is contained within the CARTON (67060-370-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/08/2015
Labeler — ADVANCED FIRST AID, INC. (114477180)
Registrant — ADVANCED FIRST AID, INC. (114477180)
Establishment
Name Address ID/FEI Operations
ULTRA SEAL CORPORATION 085752004 pack (67060-370)
Establishment
Name Address ID/FEI Operations
ULTRA TAB LABORATORIES, INC. 151051757 manufacture (67060-370)

Revised: 10/2016 ADVANCED FIRST AID, INC.

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