DUANE READE HOT AND COLD ROLL-ON- methyl salicylate and menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Duane Reade

INN (International Name):

METHYL SALICYLATE

Composition:

METHYL SALICYLATE 21.46 mL in 74 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Methyl Salicylate 29% .......................................................Topical Analgesic Menthol 7.6% ....................................................................Topical Analgesic temporarily relieves the minor pains associated with: - arthritis - cramps - bruises - sprains - backache - condition worsens - redness is present - irritation develops - symptoms persist for more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

DUANE READE HOT AND COLD ROLL-ON- METHYL SALICYLATE AND MENTHOL GEL
DUANE READE
_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._
----------
DRUG FACTS
ACTIVE INGREDIENTS PURPOSE
Methyl Salicylate 29%
.......................................................Topical
Analgesic
Menthol 7.6%
....................................................................Topical
Analgesic
US ES
temporarily relieves the minor pains associated with:
arthritis
cramps
bruises
sprains
backache
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
use only as directed
avoid contact with eyes or mucous membranes
do not bandage tightly or use with a heating pad
do not apply to wounds or damaged skin
STOP USE AND ASK A DOCTOR IF
condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again
within a few days
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS ADULTS AND CHILDREN OVER 12 YEARS:
apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but no more than 4 times daily
children under 12 years: ask a doctor
INACTIVE INGREDIENTS
purified water/aqua/eau, sd alcohol 40-b,
propylene glycol, isopropyl myristate,
glycerin, triethanolamine, carbomer
ALLERGY ALERT:
If prone to allergic reaction from aspirin or salicylates, consult a
doctor before use.
Placeholder Text
DUANE READE HOT AND COLD ROLL-ON
methyl salicylate and menthol gel
Duane Reade
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:2448 8 -0 23
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
METHYL SALICYLATE (UNII: LAV5U50 22Y) (METHYL SALICYLATE -
UNII:LAV5U50 22Y)
METHYL
SALICYLATE