Botanika Life

Manufacturer: Prime Enterprises, Inc.
Effective date: 2021-01-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:39:22

Label at a glance#

ProductBotanika Life Soothing Pain Serum

Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL

Label structure7 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Use only as directed.

Stop use and ask a doctor

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
4d7a96d5-8256-4268-9a6c-25ea66d321fe	Product name	1	20180814
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0391-3	2023-01-30	C162847	48780-1	f386c64a-136e-0266-e053-dadaa90a7c1a	Botanika Life Super Soothing Pain Serum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0391-3	Botanika LifeSoothing Pain Serum	100 mL in 1 BOTTLE, SPRAY	LIQUID	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58443-0391	BOTANIKA LIFE SOOTHING PAIN SERUM (LICOCAINE HYDROCHLORIDE, MENTHOL) LIQUID [PRIME ENTERPRISES, INC.]	1	Legacy NDC, 1 package rows	20210401_b9beb0fd-da81-6be9-e053-2995a90ac9a5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Botanika Life Soothing Pain Serum
Licocaine Hydrochloride, Menthol
LIDOCAINE HYDROCHLORIDE
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS
DIMETHYL SULFONE
ALPHA-TOCOPHEROL ACETATE
WATER
POLYISOBUTYLENE (1000 MW)
POLYSORBATE 20
ALCOHOL
INDIAN FRANKINCENSE
MENTHOL
ALOE VERA LEAF
ARNICA MONTANA FLOWER
CANNABIDIOL
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58443-0391	58443-0391-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
POLYISOBUTYLENE (1000 MW)	5XB3A63Y52	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
ALCOHOL	3K9958V90M	IACT
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
MENTHOL	L7T10EIP3A	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
CANNABIDIOL	19GBJ60SN5	IACT
GLYCERIN	PDC6A3C0OX	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b9bee8c3-8e01-4688-e053-2995a90a7f55			b9beb0fd-da81-6be9-e053-2995a90ac9a5	2021-01-25	Warnings	Exact identifier spl id: b9bee8c3-8e01-4688-e053-2995a90a7f55 spl set id: b9beb0fd-da81-6be9-e053-2995a90ac9a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.