ROOSIN BURN- lidocaine hydrochloride 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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81552-002 Burn Cream

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

label

ROOSIN BURN
lidocaine hydrochloride cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81552-002-01	0.9 g in 1 TUBE; Type 0: Not a Combination Product	04/20/2021

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

Labeler - ROOSIN MEDICAL CO., LTD (527587815)

Name	Address	ID/FEI	Business Operations
Establishment
ROOSIN MEDICAL CO., LTD		527587815	manufacture(81552-002)