Botanika Life Ultra-Relief Pain Rub

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]

BOTANIKA LIFE ULTRA-RELIEF PAIN RUB- lidocaine, menthol oil 
Prime Enterprises, Inc.

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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Botanika Life Ultra-Relief Pain Rub

Active Ingredients

Lidocaine 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 for 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 Posion 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 Extract, Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabidiol, Coconut Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Botanika Life Ultra-Repair Pain Rub

BOTANIKA LIFE  ULTRA-RELIEF PAIN RUB
lidocaine, menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0392
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	34.24 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.56 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
CANDELILLA WAX (UNII: WL0328HX19)
JOJOBA OIL (UNII: 724GKU717M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
SHEA BUTTER (UNII: K49155WL9Y)
CANNABIDIOL (UNII: 19GBJ60SN5)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0392-3	50 mL in 1 JAR; Type 0: Not a Combination Product	12/08/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/08/2020	12/31/2022

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0392) , label(58443-0392) , analysis(58443-0392) , pack(58443-0392)

Revised: 9/2022

Document Id: e9b99e94-bb33-431e-e053-2995a90acacd

34390-5

Set id: b9cf2d30-f9a1-dcfa-e053-2a95a90a3c75

Version: 2

Effective Time: 20220928