PAIN EASE- camphor, menthol, methyl salicylate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR   2.8% W/V, MENTHOL   8.8% W/V, METHYL SALICYLATE 28% W/V

Available from:

PUREVIVE HEALTH SCIENCES

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External Analgesic, Relives minor aches and pains TEMPORARILY RELIEVES: - ARTHRITIS PAIN - SORE MUSCLES - BACKACHES 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN EASE- CAMPHOR, MENTHOL, METHYL SALICYLATE LOTION
PUREVIVE HEALTH SCIENCES
_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._
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PUREVIVE HEALTH SCIENCES - PAIN EASE (71646-104)
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 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 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. 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.
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 S