ALOCANE EMERGENCY BURN- lidocaine hydrochloride gel 
Quest Products, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alocane ® Emergency Burn Gel

Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Cuts & Scrapes
  • Insect Bites

Warnings

For external use only. Avoid contact with eyes.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions:

Adults and Children 2 years of age or older:

  • Clean the burn area with mild soap and water
  • Gently apply over bthe burn or wound
  • Use on affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other Information

Store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

Distributed by:

Quest Products, LLC.

Pleasant Prairie, WI 53158

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel 2.5 fl oz tube

201-02

PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump

201-14

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count

201-07

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Station

201-12

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Spray 3.5 fl oz

201-08

ALOCANE EMERGENCY BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68229-201-021 in 1 CARTON03/01/2019
1NDC:68229-201-01110 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68229-201-03110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
3NDC:68229-201-0524 in 1 CARTON03/01/2020
3NDC:68229-201-043.4 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:68229-201-0745 in 1 CARTON03/01/2020
4NDC:68229-201-063.4 mL in 1 PACKET; Type 0: Not a Combination Product
5NDC:68229-201-08103.507 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
6NDC:68229-201-11133.081 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
7NDC:68229-201-101 in 1 CARTON03/01/2019
7NDC:68229-201-09118.294 mL in 1 TUBE; Type 0: Not a Combination Product
8NDC:68229-201-14946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2019
9NDC:68229-201-121 in 1 KIT03/01/2019
9NDC:68229-201-15800 mL in 1 BAG; Type 0: Not a Combination Product
10NDC:68229-201-131 in 1 CARTON03/01/2019
10NDC:68229-201-15800 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2019
Labeler - Quest Products, LLC. (075402441)
Establishment
NameAddressID/FEIBusiness Operations
Fill Tech USA926433855manufacture(68229-201)

Revised: 11/2020
Document Id: b479d382-073c-fd21-e053-2a95a90aa8b5
Set id: 0c8e65a6-dff3-43b4-a3f1-95deb574ea89
Version: 8
Effective Time: 20201119
 
Quest Products, LLC.