ROOSIN- hydrocortisone acetate cream

Roosin by

Drug Labeling and Warnings

Roosin by is a Otc medication manufactured, distributed, or labeled by ROOSIN MEDICAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOSIN 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81552-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81552-003-01	0.9 g in 1 TUBE; Type 0: Not a Combination Product	04/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/20/2021

Labeler - ROOSIN MEDICAL CO., LTD (527587815)

Establishment
Name	Address	ID/FEI	Business Operations
ROOSIN MEDICAL CO., LTD		527587815	manufacture(81552-003)