ALOCANE BOTANICALS- lidocaine hydrochloride spray 
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 ® Botanicals

Drug Facts

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Pain Relief

Uses

For the temporary relief of pain and itching associated with:

Warnings

For external use only. Avoid contact with eyes.

Do not use:

  • in large quantities, or over large areas of the body
  • Over raw surfaces or blistered areas
  • If you have an allergy to any of the ingredients

Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin

Stop use and ask doctor:

  • if condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions:

Adults and Children 2 years of age or older:

Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.

Children under 2 years of age, ask a doctor before use.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients

Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL -- Alocane Botanicals 4oz Spray Bottle

PDP4oz

ALOCANE BOTANICALS 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-405
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
MANNITOL (UNII: 3OWL53L36A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68229-405-01118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2023
2NDC:68229-405-02104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/11/2023
Labeler - Quest Products, LLC. (075402441)
Establishment
NameAddressID/FEIBusiness Operations
Fill Tech USA926433855manufacture(68229-405)

Revised: 8/2023
Document Id: 02a8e5c7-56f5-eb0d-e063-6294a90a80cd
Set id: 02a8e5c7-56f4-eb0d-e063-6294a90a80cd
Version: 1
Effective Time: 20230811
 
Quest Products, LLC.