FIRST AID BURN CREAM- lidocaine cream

First Aid Burn Cream by

Drug Labeling and Warnings

First Aid Burn Cream by is a Otc medication manufactured, distributed, or labeled by Davemed Healthcare Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredient

Lidocaine HCL 0.5%

Benzalkonium Chloride 0.13%

Purpose

First aid antiseptic, external analgesic

Temporary relief of pain associated with minor burns

Uses

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

WARNINGS

EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

If ingested, get medical help or contact a Poison Control Center right away.

DO NOT USE

DO NOT USE:

• in eyes
• in large quantities
• over raw blistered areas or on deep punctured wounds, animal bites or serious burns
• for more than one week

Directions

• Clean affected area
• apply small amount not more than 3 times daily
• maybe covered with a sterile bondage

Inactive ingredients

inactive ingredient

Other Information

Other Information

Store at room temperature

Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRST AID BURN CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70897-001
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
METHYL PARAOXON (UNII: UE1A2XL95H)
PETROLATUM (UNII: 4T6H12BN9U)
DIISOPROPYL PARAOXON (UNII: R90A2849YV)
ALLANTOIN (UNII: 344S277G0Z)
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)
STEARIC ACID D7 (UNII: T3B081197X)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70897-001-01	0.9 g in 1 BAG; Type 0: Not a Combination Product	08/11/2016
2	NDC: 70897-001-02	42.5 g in 1 BAG; Type 0: Not a Combination Product	08/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/09/2016

Labeler - Davemed Healthcare Co., Ltd (529128716)

Establishment
Name	Address	ID/FEI	Business Operations
Davemed Healthcare Co., Ltd		529128716	manufacture(70897-001)