Ecolab Burn Cream (Benzaalkonium Chloride, Lidocaine Hcl) Cream [Ecolab Food Safety Specialties, Inc.] -

ECOLAB BURN CREAM (BENZAALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [ECOLAB FOOD SAFETY SPECIALTIES, INC.]
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NDC	71338-123-73
Set ID	4b2a7da9-c0e9-61c5-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	ECOLAB Food Safety Specialties, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART333A

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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%
PURPOSE

Purpose

Topical antiseptic

Topical analgesic
Uses
First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relif of pain and itching associated with:
- sunburn
- minor burns
- insect bites
- minor skin irritation
- cuts
- scrapes
WARNINGS
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
- condition gets worse
- condition clears up and recurs within a few days
- condition persists for more than 7 days
PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health care professional before use.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.
DOSAGE & ADMINISTRATION
Directions

Adults and children 12 years and over
- clean the affected area
- apply a small amount of this product on the area 3 times daily
- may be covered with a sterile bandage
Children under 12 years
- consult a doctor
OTHER SAFETY INFORMATION
Other information
- store in a cool dry area 59° to 79°F (15° to 25°C)
- tamper evident sealed packets
- do not use any opened or torn packets
INACTIVE INGREDIENT

Inactive ingredients

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

Questions or comments? 1-800-321-3687
ECOLAB Burn Cream Label

ANSI/ISEA Required

ECOLAB®

Burn Cream

(with Lidocaine)

Reorder # 7

0.9g (1/32oz) Packets

25 per Box

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Topical analgesic with aloe

for minor cuts, scrapes and burns

INGREDIENTS AND APPEARANCE

ECOLAB BURN CREAM
benzaalkonium chloride, lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71338-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PARAFFIN (UNII: I9O0E3H2ZE)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71338-123-73	25 in 1 BOX	03/20/2017
1		0.9 g 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	part333A	03/20/2017

Labeler - ECOLAB Food Safety Specialties, Inc. (618996086)

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ECOLAB BURN CREAM (BENZAALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [ECOLAB FOOD SAFETY SPECIALTIES, INC.]

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