ALOCANE EMERGENCY BURN PADS- lidocaine hydrochloride swab

Alocane Emergency Burn Pads by

Drug Labeling and Warnings

Alocane Emergency Burn Pads by is a Otc medication manufactured, distributed, or labeled by Quest Products, Inc., Fill Tech USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Bums, Insect Bites and minor Skin Irritation, Cuts and Scrapes.

Warnings

For external use only. Avoid contact with eyes.

Keep out of reach of children.

Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health care professional before use.

Directions

Adults and children 2 years of age or older

Clean the burn area with mild soap and water. Gently apply the Alocane Pad over the burn or wound. Cover with adhesive tape or stretch gauze. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Other Information

Store in a cool, dry area.

Inactive Ingredients

1,3-Propanediol, Aloe Barbadensis (Aloe) leaf Juice, Dimethyl lsosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Tocopheryl Acetate (Vitamin El, Water.

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Distributed by:
Quest Products, Inc.
Pleasant Prairie, WI 53158

PRINCIPAL DISPLAY PANEL - 10 Pad Box

4% Lidocaine
Maximum Strength

USED IN HOSPITALS
BURN CENTERS

MAXIMUM STRENGTH

ALOCANE®

Emergency
Burn Pads

• Fast Pain and Cooling Relief
• Infused with Alocane® Burn Gel
• Speeds the Healing Process
• Protects & Cushions

Aloe
BRAZILIAN

MADE IN THE
USA

Contains: 10 Individual
Sterile 1.25"x 2.5" Pads

INGREDIENTS AND APPEARANCE

ALOCANE EMERGENCY BURN PADS 
lidocaine hydrochloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Dimethyl Isosorbide (UNII: SA6A6V432S)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)
Caprylyl Glycol (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-403-02	10 in 1 BOX	02/13/2017
1	NDC: 68229-403-01	3 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/13/2017

Labeler - Quest Products, Inc. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		926433855	MANUFACTURE(68229-403)