ROOSIN- hydrocortisone acetate cream 
ROOSIN MEDICAL CO., LTD

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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81552-003 Hydrocortisone Cream

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Use

 Temporary relieves itching associated with minor irritations and rashes

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

WARNINGS

For external use only

Do not use

  • In or near eyes
  • For diaper rash, consult a doctor

When using this product

  • Do not use any other hydrocortisone products unless you have contacted a doctor

Stop use and ask a doctor if

Condition worsens or persists for more than 7 days

Symptoms clear up and occur within a few days

Keep out of reach of children. If ingested, get medical help or contact a poison control center right away

Directions

Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily

Children under 2 years of age: Do not use

Inactive ingredients

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

Other Information

Store at room temperature

image description

ROOSIN 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81552-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCEROL FORMAL (UNII: 3L7GR2604E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81552-003-010.9 g in 1 TUBE; Type 0: Not a Combination Product04/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/20/2021
Labeler - ROOSIN MEDICAL CO., LTD (527587815)
Establishment
NameAddressID/FEIBusiness Operations
ROOSIN MEDICAL CO., LTD527587815manufacture(81552-003)

Revised: 12/2021
Document Id: d3325152-47bb-d0af-e053-2a95a90aa916
Set id: e8154890-eb2f-42c1-a594-9f2a40424b04
Version: 2
Effective Time: 20211215
 
ROOSIN MEDICAL CO., LTD