MEDROX- methyl salicylate, menthol, capsaicin ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Methyl Salicylate      20.00%, Menthol                     5.00%, Capsaicin                  0.0375%

Available from:

Dispensing Solutions, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Analgesic/Counterirritant Analgesic/Counterirritant External Analgesic Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MEDROX- METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT
DISPENSING SOLUTIONS, 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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MEDROX (MEDROXIN)
DRUG FACTS:
ACTIVE INGREDIENTS
Methyl Salicylate 20.00%
Menthol 5.00%
Capsaicin 0.0375%
PURPOSE
Analgesic/Counterirritant
Analgesic/Counterirritant
External Analgesic
USES
Use for the temporary relief of minor aches and muscle pains
associated with arthritis, simple backache,
strains, muscle soreness and stiffness.
WARNINGS
For external use only. Use only as directed. Avoid contact with eyes
and mucous membranes.
Do not cover with bandage.
Do not use on wounds or damaged skin.
KEEP OUT OF REACH OF CHILDREN
Consult physician for children under 12.
DIRECTIONS
Apply product directly to affected area. Product may be used as
necessary, but should not be used more
than four times per day.
OTHER INGREDIENTS
Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl
Myristate, Glycerin, Sodium Lauryl
Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer,
Propylene Glycol, Methyl Paraben,
Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68258-3984-04
MEDROX
methyl salicylate, menthol, capsaicin ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 258 -39 8 4(NDC:458 6 1-0 0 1)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
20 g in 10 0 g
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
5 g in 10 0 g
CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)
CAPSAICIN
0 .0 375 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CETYL ALCO HO L (UNII: 9 36 JST6 JCN)
PEG-150 DISTEARATE (UNII: 6 F36 Q0