ANTISEPTIC- benzalkonium chloride, lidocaine hydrochloride cream

Burn Cream by

Drug Labeling and Warnings

Burn Cream by is a Otc medication manufactured, distributed, or labeled by Total Resources International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzalkonium

Chloride 0.13% w/w

Lidocaine

HCI 0.5% w/w

Purpose

First Aid

Antiseptic

Topical

Analgesic

Uses

• temporary relief of pain associated with minor burns
• helps protect against harmful bacteria

Warnings

For external use only

Do not use

• in eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
• for more than one week unless directed by a doctor

Keep out of reach of children If ingested contact a Poison Control Center right away

Directions

• clean affected area
• apply small amount not more than 3 times daily
• children under 2: consult a doctor

Inactive ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel – Pouch Label

BE SMART

GET PREPARED

BURN
CREAM
W/ ALOE VERA FOR MINOR BURNS

0.03 oz [0.90 g]

SINGLE USE

Made in USA Mfd. for: TOTAL RESOURCES INTL.
Walnut, California 91789

00-BUR-0009 Rev.01 NDC #55550-902-21

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55550-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	1.3 mg  in 1 g
lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)	lidocaine hydrochloride anhydrous	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
alcohol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)
white wax (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55550-902-21	0.9 g in 1 POUCH; Type 0: Not a Combination Product	01/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2020

Labeler - Total Resources International (790160535)