PAINSHIELD- menthol cream

PainShield by

Drug Labeling and Warnings

PainShield by is a Otc medication manufactured, distributed, or labeled by Nutranext LLC, Accupack Midwest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

ACTIVE INGREDIENT

Active ingredient

Menthol USP 3.7%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses temporarily relieves minor aches and pains of muscles and joints due to

• arthritis
• simple backaches
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only Flammable: Keep away from fire or flame.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• with other ointments, creams, sprays or liniments

WHEN USING

When using this product

• avoid contact with eyes
• do not bandage tightly
• wash hands with cool water after use

STOP USE

Stop use and ask a doctor if

• condition worsens or rash or irritation develops
• symptoms last more than 7 days
• condition clears up and occurs again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

adults and children 12 years of age and older: apply and massage onto affected area no more than 3 to 4 times daily
children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• close cap tightly
• store in a cool, dry place

INACTIVE INGREDIENT

Inactive ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Carbomer, Dimethyl Sulfone(MSM), EDTA, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamins B6), Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutylparabens, Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate, Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured and Distributed by Stop Aging Now as Nutranext Direct, LLC

1301 Sawgrass Corporate Parkway, Sunrise, FL 33323 800-627-9721

NDC# 72914-0001-1

PRINCIPAL DISPLAY PANEL

PainShield™

Advanced Pain Relief Cream for Arthritis, Joint, Muscle and Back Pain

Cooling Menthol

Net Wt. 6 oz. (170 grams)

INGREDIENTS AND APPEARANCE

PAINSHIELD 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72914-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TROLAMINE (UNII: 9O3K93S3TK)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72914-0001-1	170 g in 1 JAR; Type 0: Not a Combination Product	03/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/15/2019

Labeler - Nutranext LLC (968031174)

Establishment
Name	Address	ID/FEI	Business Operations
Accupack Midwest		139637433	manufacture(72914-0001)