ASSURED COLD N HOT PAIN RELIEF MENTHOL- menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Greenbrier International, Inc

INN (International Name):

MENTHOL

Composition:

MENTHOL 5 mg in 100 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses Temporarily relieves minor pains associated with: - arthritis - simple backache - bursitis - tendonitis - muscle strains - muscle cramps Do not use - on wounds or damaged skin - with a heating pad - on a child under 12 years of age with arthritis-like conditions Stop use and ask a doctor if - condition worsens or symptoms persist more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation occurs Directions - ​ open pouch and remove patch - carefully peel off protective packing and apply sticky side to affected area - adults and children 12 years of age and older: - do not wear patch for more than 8 hours - apply to affected area no more than 3 times daily - children under 12 years of age: consult a doctor

Authorization status:

OTC monograph not final

Summary of Product characteristics

ASSURED COLD N HOT PAIN RELIEF MENTHOL- MENTHOL PATCH
GREENBRIER INTERNATIONAL, 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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ASSURED COLD'N HOT MEDICATED PATCH 2CT 6159, 2020
Active Ingredient Purpose
Menthol 5%---------------------------------------------------------
Topical analgestic
Uses
Temporarily relieves minor pains associated with:
arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle cramps
Warnings
For external use only
DO NOT USE
on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions
ASK A DOCTOR BEFORE USE IF YOU HAVE
redness over the affected area
When using this product
use as only directed
avoid contact with eyes and mucous membranes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
Stop use and ask a doctor if
condition worsens or symptoms persist more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs
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 (1-
800-222-1222) right away.
DIRECTIONS
open pouch and remove patch
carefully peel off protective packing and apply sticky side to
affected area
adults and children 12 years of age and older:
do not wear patch for more than 8 hours
apply to affected area no more than 3 times daily
children under 12 years of age: consult a doctor
OTHER INFORMATION
store at room temperature 20-25°C (68-77°F)
Inactive ingredients
aloe vera, aluminum hydroxide, BHT, castor oil, concentrated glycerin,
disodium edetate hydrate, dried
aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin,
magnesium aluminosilicate, methyl
paraben, peg monostearate, polysorbate 80, polyvinyl alcohol, purifi