MR DUDLEYS TOPICAL PAIN RELIEF- menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DUDLEY WELLNESS COMPANY INC

INN (International Name):

MENTHOL

Composition:

MENTHOL 2.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic For the temporary relief of minor arthritis pain, backache, muscle strains and cramps.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MR DUDLEYS TOPICAL PAIN RELIEF - MENTHOL CREAM
DUDLEY WELLNESS COMPANY 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._
----------
DRUG FACTS
ACTIVE INGREDIENT:
Menthol 2.5%
PURPOS E:
Topical Analgesic
US ES :
For the temporary relief of minor arthritis pain, backache, muscle
strains and cramps.
KEEP OUT OF THE REACH OF CHILDREN
WARNINGS :
For external use only.
Use only as directed.
Do not apply to wounds or damaged skin.
If redness is present, discontinue use and consult a doctor.
Do not bandage tightly or use a heating pad.
If the condition persists for more than 5 days, discontinue use and
consult a doctor.
Avoid contact with eyes and other mucous membranes.
If you are pregnant or nursing a baby, seek the advice of a healthcare
professional before using this
product.
DIRECTIONS :
Apply generously and massage into the affected area until thoroughly
absorbed into the skin. Repeat as
needed for pain, but not more than 4 times per day.
INACTIVE INGREDIENTS:
Water, SD Alcohol, Glycerine, PEG-40 Hydrogenated Castor Oil, Methyl
Salicylate, Caprylic Capric
Triglyceride, Sodium Acrylate Copolymer, Eugenol, Methyl Eugenol,
Nutmeg Oil, Methyllisoeugenol,
Methoxy Eugenol, Blue #1
PRODUCT LABEL
MR DUDLEYS TOPICAL PAIN RELIEF
menthol cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:58 48 4-10 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
2.5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
GLYCERIN (UNII: PDC6 A3C0 OX)
PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)
METHYL SALICYLATE (UNII: LAV5U50 22Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)
DUDLEY WELLNESS COMPANY INC
ACRYLAMIDE (UNII: 20 R0 35KLCI)
EUGENO