1% Hydrocortisone Cream MAXIMUM STRENGTH

Hydrocortisone 1% by

Drug Labeling and Warnings

Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROCORTISONE 1%- hydrocortisone cream 
Trifecta Pharmaceuticals Usa Llc

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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1% Hydrocortisone Cream







MAXIMUM STRENGTH

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Keep out of the reach of children.

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

Uses

For temporary relief of itching associated with minor skin irritations and rashes

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Do Not Use

  • For the treatment of diaper rash, consult a doctor.
  • With any other Hydrocortisone product unless you have consulted a doctor
  • If you have a vaginal discharge, consult a doctor

Warnings

For external use only

When using this product

  • Avoid Contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop using this product and ask a doctor if

  • conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
  • Rectal bleeding occurs

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use and ask a doctor.

For External and anal itching in adults:

When practical, clean affected area with mild soap and warm water and rinse thoroughly

Gently dry by patting or blotting with toilet tissue or a soft cloth before applying

For External anal and genital itching in children under 12 years of age:

Ask a doctor

Inactive ingredients

Benzoic Acid, Chlorphenesin, citric acid, glycerin, glycerol monostearate, methylparaben, mineral oil, petrolatum, Phenoxyethanol, Polysorbate 80, purified water, titanium dioxide, trisodium citrate

Other information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Tamper evident, do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

Distributed by:

Trifecta Pharmaceuticals USA™

Ft. Lauderdale, FL 33301 USA

Online: www.trifecta-pharma.com

Reorder No. 1016SL

To reorder call: 1-888-296-9067

Fax: 888-878-3609

Questions

Call 1-888-296-9067

Packaging

hydrocortisone-cream-09g

HYDROCORTISONE 1% 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69396-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MINERAL OIL (UNII: T5L8T28FGP)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69396-069-09144 in 1 CARTON11/24/2020
10.9 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 finalpart34811/19/202011/19/2020
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 7/2023