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.

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-370-3925 in 1 CARTON04/08/201507/01/2024
1NDC:67060-370-090.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/08/201507/01/2024
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-370)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-370)

Revised: 1/2023
Document Id: f1b3aeb8-a1bb-a481-e053-2a95a90a19ad
Set id: 0beabef1-13c2-426f-96a4-722973843c09
Version: 4
Effective Time: 20230107
 
ADVANCED FIRST AID, INC.