Sky Wellness CBD max Pain Relief Roll-On

Sky Wellness by

Drug Labeling and Warnings

Sky Wellness by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKY WELLNESS MAX PAIN RELIEF- lidocaine hydrochloride, menthol stick 
Prime Enterprises

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.

----------

Sky Wellness CBD max Pain Relief Roll-On

Active Ingredient

Lidocaine Hydrochloride 4%, Menthol 1%

Purpose

Topical Analgesic

Use

Use for temporary relief of minor pain

Warnings

For external use only.

Do not use

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

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

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.

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

If pregnant or breast-feeding

ask a health professional before use.

Directions

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

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

SKY WELLNESS  MAX PAIN RELIEF
lidocaine hydrochloride, menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9.62 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	38.48 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
SALIX ALBA BARK (UNII: 205MXS71H7)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHAMOMILE (UNII: FGL3685T2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
PEPPERMINT OIL (UNII: AV092KU4JH)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
BLACK CURRANT (UNII: 9755T40D11)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
ACRYLAMIDE (UNII: 20R035KLCI)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
MINERAL OIL (UNII: T5L8T28FGP)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
BORAGE SEED OIL (UNII: F8XAG1755S)
CANNABIDIOL (UNII: 19GBJ60SN5)
TURMERIC (UNII: 856YO1Z64F)

Product Characteristics
Color	white (White to Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0370-3	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019	12/31/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0370) , label(58443-0370) , analysis(58443-0370) , pack(58443-0370)

Revised: 9/2022

Document Id: e9a994d7-532a-ae86-e053-2995a90a9a19

34390-5

Set id: b1a64641-842b-17a8-e053-2a95a90a2007

Version: 2

Effective Time: 20220927