FDA.reportPublic FDA data

Botanika Life

Manufacturer
Prime Enterprises, Inc.
Effective date
2022-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:52:44

Label at a glance#

ProductBotanika Life Ultra-Relief Pain Rub
Active ingredientLIDOCAINE, 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 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 if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Posion 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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-039258443-0392-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
CANDELILLA WAXWL0328HX19IACT
JOJOBA OIL724GKU717MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
SHEA BUTTERK49155WL9YIACT
CANNABIDIOL19GBJ60SN5IACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
ALMOND OIL66YXD4DKO9IACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e9b99e94-bb33-431e-e053-2995a90acacdb9cf2d30-f9a1-dcfa-e053-2a95a90a3c752022-09-28WarningsExact identifier
spl id: e9b99e94-bb33-431e-e053-2995a90acacd
spl set id: b9cf2d30-f9a1-dcfa-e053-2a95a90a3c75

Reported adverse events (FAERS/openFDA)#

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