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

1165 First Aid Burn Cream

1165UB-10 Label

1165UB-10_BX_MASTER 1165UB-10

1165UB-25 Label

1165UB-25_BX_MASTER

BURN FIRST AID
burn first aid cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/17/2018

Labeler - Dynarex Corporation (008124539)

1165 First Aid Burn Cream NDC 67777-007-50 1165UB-10 First Aid Burn Cream NDC 67777-007-52 1165UB-25 First Aid Burn Cream NDC 67777-007-54

Active Ingredient

Purpose

Active Ingredient

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

If pregnant or breast feeding,

Directions

Other Information

Inactive Ingredients

1165 Label

1165UB-10 Label

1165UB-25 Label

1165 First Aid Burn Cream NDC 67777-007-50
1165UB-10 First Aid Burn Cream NDC 67777-007-52
1165UB-25 First Aid Burn Cream NDC 67777-007-54