MENTHOL 5% HYDROGEL- menthol, unspecified form patch

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Download Productkenmerken (SPC)
18-01-2022

Werkstoffen:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Beschikbaar vanaf:

Unexo Life Sciences, Private Limited

Toedieningsweg:

TOPICAL

Prescription-type:

OTC DRUG

therapeutische indicaties:

Topical Analgesic For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Autorisatie-status:

OTC monograph not final

Productkenmerken

                                MENTHOL 5% HYDROGEL- MENTHOL, UNSPECIFIED FORM PATCH
UNEXO LIFE SCIENCES, PRIVATE LIMITED
_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._
----------
MENTHOL 5% HYDROGEL PATCH
_DRUG FACTS_
ACTIVE INGREDIENT
Menthol 5%
PURPOSE
Topical Analgesic
USE
For temporary relief of minor aches and pains of muscles and joints:
arthritis, simple
backache, bursitis, tendonitis, muscle strains, muscle sprains,
bruises and cramps
WARNINGS
_FOR EXTERNAL USE ONLY_
WHEN USING THIS PRODUCT
Use only as directed
Rare cases of serious burns have been reported with products of this
type
Don't bandage tightly or use with a heating pad
Avoid contact with eyes or mucous membranes
Don't apply to wounds or damaged skin
Do not use at the same time as other topical analgesics
STOP USE AND CONSULT 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
You experience signs of skin injury such as pain, swelling, or
blistering where the
product was applied.
IF PREGNANT OF BREASTFEEDING, ask a health professional before use
KEEP OUT OF REACH OF CHILDREN. Do not use on infants. If swallowed,
seek medical
help or contact a Poison Control Centre right away.
DIRECTIONS
Adults and children 12 years of age and over: Carefully remove backing
from patch.
Applu sticky side of patch to affected area. Wear one patch up to 8
hours. Repeat as
necessary, but no more than 3 times daily. Discard patch after single
use. Reseal
pouch after opening. Children under 12 years of age consult a
physician.
OTHER INFORMATION
Store at room temperature below 86°F (30°C)
INACTIVE INGREDIENTS
acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate
Disodium,
dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben,
polysorbate 80,
polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan
ol
                                
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