Botanika Life

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:30:32

Label at a glance#

ProductBotanika Life Pain Relief Roller
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE
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

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. Use only as directed.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant of breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breast-feeding, 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, Sodium Hydroxide, Tocopheryl Acetate, Water

Botanika Life Pain Relief Roller + Lidocaine + Menthol + CBD - 90 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-040358443-0403-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
dbda58c5-891f-7433-e053-2995a90a94c8bf534765-1c62-45f7-e053-2995a90af9562022-04-04WarningsExact identifier
spl set id: bf534765-1c62-45f7-e053-2995a90af956

Reported adverse events (FAERS/openFDA)#

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