ROOSIN BURN- lidocaine hydrochloride cream

Roosin Burn by

Drug Labeling and Warnings

Roosin Burn 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

Banzalkonium Chloride 0.13%

Lidocaine Chloride 0.5%

Purpose

First Aid Antiseptic

External Analgesic

Antiseptic and antipyrotic

Use

First aid to help prevent infection and for temporary relief of pain and itching associated with minor cuts scrapes burns

WARNINGS

For external use only

Do not use

• In eyes
• Over large areas of the body
• For more than one week unless directed by a doctor
• If you are allergic to any of the ingredients
• On deep puncture wounds, animal bites, or serious burns

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

Directions

Clean affected area

Apply a small amount 1-3 times daily

Children under 2: Consult doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOSIN BURN 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81552-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
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: 81552-002-01	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(81552-002)