Sky Wellness

Manufacturer
Prime Enterprises
Effective date
2022-09-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:52:52

Label at a glance#

ProductSky Wellness Max Pain Relief
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily if product comes in contact hands, wash hands with soap and water

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%, Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Use for temporary relief of minor pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on large areas of the body or on cut, irritated or swollen skin

on puncture wounds

for more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

use only as directed

avoid contact with eyes and mucous membranes

do not apply to skin folds

do not apply to wounds or damaged, broken or irritated skin

do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens

irritation develops

redness appears

symptoms persist for more than 7 days or clear up and occurs 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 over 12 years:

apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily

if product comes in contact hands, wash hands with soap and water

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Cannabidiol, Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water

Sky wellness CBD Max pain relief Roll-on

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 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-037058443-0370-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 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
e9a994d7-532a-ae86-e053-2995a90a9a19b1a64641-842b-17a8-e053-2a95a90a20072022-09-27WarningsExact identifier
spl id: e9a994d7-532a-ae86-e053-2995a90a9a19
spl set id: b1a64641-842b-17a8-e053-2a95a90a2007

Reported adverse events (FAERS/openFDA)#

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