ALOCANE SEVERE SUNBURN- lidocaine hydrochloride gel

Alocane Severe Sunburn by

Drug Labeling and Warnings

Alocane Severe Sunburn 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]

Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Burns, 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

Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician. 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 Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Tocopheryl Acetate (Vitamin E), Water.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton

4% Lidocaine
Maximum Strength

After
Sun

MAXIMUM STRENGTH
ALOCANE®

Severe
Sunburn Gel

• Assists the Healing of Sunburned Skin
• Cools and Rehydrates Skin
• Soothing Aloe Gel & Vitamin E

Aloe
BRAZILIAN

Net Wt
2.5 fl. oz (75ml)

INGREDIENTS AND APPEARANCE

ALOCANE SEVERE SUNBURN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-401
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: 68229-401-02	1 in 1 CARTON	02/13/2017
1	NDC: 68229-401-01	75 mL in 1 TUBE; 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(68229-401)