Burn First Aid by Dynarex Corporation BURN FIRST AID cream

Burn First Aid by

Drug Labeling and Warnings

Burn First Aid by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 0.5%

Purpose

Topical analgesic

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Topical antiseptic

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, scrapes

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body or on deep puncture wounds, animal bites, or serious burns
• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

• the condition gets worse
• condition clears up and recurs within a few days
• condition persists for more than 7 days

If pregnant or breast feeding,

ask a health care professional before use.

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

Directions

Adults and children 2 years and over:

• clean the affected area
• apply a small amount of this product on the area 3 to 4 times daily
• may be covered with a sterile bandage

Children under 2 years:

• consult a doctor

Other Information

• store in a cool, dry area 15°-25° C (59°-79° F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

1165 Label

1165UB-10 Label

1165UB-10

1165UB-25 Label

INGREDIENTS AND APPEARANCE

BURN FIRST AID 
burn first aid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	50 mg  in 10000 mg
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 10000 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
CETETH-20 (UNII: I835H2IHHX)
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-007-50	1728 in 1 CASE	09/17/2018
1	NDC: 67777-007-49	144 in 1 BOX
1		900 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67777-007-52	1000 in 1 CASE	09/17/2018
2	NDC: 67777-007-51	10 in 1 BOX
2		900 mg in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 67777-007-54	1800 in 1 CASE	09/17/2018
3	NDC: 67777-007-53	25 in 1 BOX
3		900 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/17/2018

Labeler - Dynarex Corporation (008124539)