Burn First Aid Cream [Dynarex Corporation] -

BURN FIRST AID CREAM [DYNAREX CORPORATION]
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NDC	67777-007-50
Set ID	826e08be-dffa-5a27-e053-2a91aa0a8701
Category	HUMAN OTC DRUG LABEL
Packager	Dynarex Corporation
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

INGREDIENTS AND APPEARANCE

BURN FIRST AID
burn first aid cream

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)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
CETETH-20 (UNII: I835H2IHHX)
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67777-007-50	1728 in 1 CASE	09/17/2018
1		144 in 1 BOX
1		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 not final	part348	09/17/2018

Labeler - Dynarex Corporation (008124539)

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Medic