PainZone Light by MEDZONE PRODUCTS LLC / Dhaliwal Laboratories LLC PAINZONE LIGHT cream

PainZone Light by

Drug Labeling and Warnings

PainZone Light by is a Otc medication manufactured, distributed, or labeled by MEDZONE PRODUCTS LLC, Dhaliwal Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

• Active Ingredient: Use
• Menthol 3.5%: Topical Analgesic

Uses

Uses:

• For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains

Do Not Use

Do not use:

• On wounds or damaged skin
• With a heating pad
• On children under 12 years of age
• If pregnant or breast feeding

Stop use and ask a physicinan if:

Stop use and ask a physician if:

• Conditiion worsens or symtops persist for more than 7 days
• Symptoms clear up and occur again within a few days
• Excessive skin irritation occurs

Directions

Directions
Use only as directed
Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
Children under 12 years of age consult a physician
Wash hands after applying

Storage

Store at 68-86 degrees with lid tightly closed

Inactive Ingredient

Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

Warnings For External Use Only:

Warnings For External Use Only:

• Avoid contact with eyes and mucous membranes. Do not bandage tightly

Distributed By

Distributed by: MedZone

Lenexa, Kansas

Ph 913-948-9663

www.medzonecorp.com

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAINZONE LIGHT 
painzone light cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-651
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
ALCOHOL (UNII: 3K9958V90M)
PINEAPPLE (UNII: 2A88ZO081O)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
LAURETH-4 (UNII: 6HQ855798J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-651-01	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

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

Labeler - MEDZONE PRODUCTS LLC (080083739)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories LLC		016754201	manufacture(70338-651)