PAIN EASE- camphor, menthol, methyl salicylate lotion

PAIN EASE by

Drug Labeling and Warnings

PAIN EASE by is a Otc medication manufactured, distributed, or labeled by PUREVIVE HEALTH SCIENCES, Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

CAMPHOR   2.8% W/V

MENTHOL   8.8% W/V

METHYL SALICYLATE 28% W/V

PURPOSE

External Analgesic, Relives minor aches and pains

USES

TEMPORARILY RELIEVES:

• ARTHRITIS PAIN
• SORE MUSCLES
• BACKACHES

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE IF

• SAFETY SEAL IS BROKEN, OR HAS BEEN TAMPERED WITH

STOP USE

STOP USE AND ASK A PHYSICIAN IF

• SYMPTOMS PERSIST FOR MORE THAN 7 DAYS
• SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
• CONDITION WORSENS

WHEN USING

WHEN USING THIS PRODUCT

• AVOID CONTACT WITH EYES, MOUTH, GENITALIA AND BROKAN SKIN
• DO NOT APPLY TO WOUNDS OR DAMAGED SKIN
• DO NOT BANDAGE OR APPLY EXTERNAL HEAT TO AFFECTED AREA

OTHER INFORMATION

• KEEP CAP TIGHTLY CLOSED

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LOTION TO PAINFUL AREA
• RUB INTO SKIN
• REPEAT AS NEEDED

ADULTS AND CHILDREN 12 YEARS AND OLDER - USE AS DIRECTED

CHILDREN UNDER 12 YEARS - DO NOT USE

INACTIVE INGREDIENTS

Carthamus Tinctorius (Safflower) Oil, Ceteth 20, Cetyl Alcohol, Disodium EDTA, Fragrance, Glyceryl Stearate, Isopropyl Myristate, Lecithin, Magnesium Aluminum Silicate, Methyylparaben, PEG-75 Stearate, PEG-100 Stearate, Polaxamer 407, Propylparaben, SDA 40-B, Steareth 20, Stearic Acid, Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN EASE 
camphor, menthol, methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71646-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	2.8 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.8 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER OIL (UNII: 65UEH262IS)
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-75 STEARATE (UNII: OT38R0N74H)
PEG-100 STEARATE (UNII: YD01N1999R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-20 (UNII: L0Q8IK9E08)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71646-104-11	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/14/2017

Labeler - PUREVIVE HEALTH SCIENCES (080596378)

Registrant - PUREVIVE HEALTH SCIENCES (080596378)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(71646-104)