OVERTIME-X- methyl salicylate, menthol, capsaicin lotion

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
01-03-2019

active_ingredient:

Methyl Salicylate 30%, Menthol 10%, Capsaicin 0.025%

MAH:

Physician’s Science & Nature Inc.

INN:

METHYL SALICYLATE

composition:

METHYL SALICYLATE 30 g in 100 mL

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Topical Analgesic For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

authorization_status:

OTC monograph not final

SPC

                                OVERTIME-X- METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION
PHYSICIAN’S SCIENCE & NATURE INC.
_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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DRUG FACTS
ACTIVE INGREDIENTS
Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%
PURPOS E
Topical Analgesic
USES:
For temporary relief of mild pain due to muscular strain, arthritis,
and simple back pain. Does not cure
any disease.
WARNINGS:
For external use only. Do not use in eyes, mouth, on mucous membranes,
or genitals. Do not tightly
bandage. Do not use with heating pad. Do not use with other topical
pain products. May stain furniture.
KEEP OUT OF REACH OF CHILDREN AND PETS
Keep away from children and pets. Do not allow treated skin to contact
infants or pets.
DIRECTIONS:
Use only as directed. Shake before each use. Prior to first use, rub
small amount to check for
sensitivity. Gently rub over painful areas. Dry before contact with
clothes or bedding to avoid staining.
Wash hands after use. Do not use more than 4 times daily or if
pregnant or nursing. If swallowed, call
poison control. If placed into eyes, rinse with cold water and call a
doctor.
DO NOT USE:
On cuts or infected skin, on children less than 12 years old, on pets,
in large amounts, especially over
raw or blistered skin, if allergic to any ingredients, PABA, aspirin
products, or sulfa. STORE BELOW
90 F/32 C.
STOP USE AND ASK A PHYSICIAN:
For severe undiagnosed pain. If pain worsens or persist for more than
7 days. If pain clears up and then
recurs in a few days. If itching or rash occurs.
INACTIVE INGREDIENTS:
O
O
water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid,
cetyl alcohol, propylene glycol,
dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis
gel, borage oil, ammonium
acryloyldimethyltaurate, zingiber officinale root extract,
methylparaben, propylparaben, soya lecithin,
DMDM hydantoin sodium stearoy
                                
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