HERBAL- menthol and methyl salicylate oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Albert Max, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External analgesic Temporarily relieves minor aches and pains of muscles and joints due to: - simple backache - arthritis - strains - bruises - sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

HERBAL- MENTHOL AND METHYL SALICYLATE OIL
ALBERT MAX, 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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HERBAL OIL
DRUG FACTS
ACTIVE INGREDIENTS
Menthol 10%
Methyl Salicylate 5%
PURPOS E
External analgesic
US ES
Temporarily relieves minor aches and pains of muscles and joints due
to:
simple backache
arthritis
strains
bruises
sprains
WARNINGS
DO NOT USE IF PREGNANT OR BREAST-FEEDING.
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
use only as directed
do not get into the eyes or mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
STOP USE AND ASK A DOCTOR IF
excessive irritation develops
pain worsens or does not improve within 7 days or clears up and
appears again in a few days
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Adults and children 2 years of age and older: apply to affected area
not more than 3 to 4 times daily
Children under 2 years of age: ask a doctor
INACTIVE INGREDIENTS
Saposhnikoviae Radix, Crossostephium Chinese, Moutan Radicis Cortex,
Carpesii Fructus,
Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Herba Clematidis
Intricatae, Paeoniae Rubra
Radix, Zanthoxyli Pericarpium, Glycyrrhizae Radix Et Rhizoma, Ocimum
Basilicum, Notoginseng
Radix Et Rhizoma, Carthami Flos, Ethyl Alcohol
PRINCIPAL DISPLAY PANEL
HERBAL OIL
Distributed by:
TN America Herbs LLC
15361 Brookhurst #104
Westminster, CA 92683
Tel. [phone]
www.tnamaericaherbal.com
Made in Taiwan
HERBAL
menthol and methyl salicylate oil
TM
Albert Max, Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 233-8 11
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
0 .1 g in 1 mL
METHYL SALICYLATE (UNII: LAV5