BOTANIKA LIFE SOOTHING PAIN SERUM- licocaine hydrochloride, menthol liquid

Botanika Life by

Drug Labeling and Warnings

Botanika Life by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hydrochloride 4%

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

avoid contact with the eyes.

Use only as directed.

Stop use and ask a doctor

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

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions

Adults and children 2 years of age and older:

Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabidiol, Dimethyl Sulfone, Glycerin, Polyacrylate-13, Polyisobutene, Polysorbate 20, SD Alcohol 40-B, Tocopheryl Acetate, Water

Botanika Life Super Soothing Pain Serum

INGREDIENTS AND APPEARANCE

BOTANIKA LIFE  SOOTHING PAIN SERUM
licocaine hydrochloride, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0391
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	38.44 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9.61 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CANNABIDIOL (UNII: 19GBJ60SN5)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (White to Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0391-3	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/19/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0391) , label(58443-0391) , analysis(58443-0391) , pack(58443-0391)