ZANDU BALM- menthol and methyl salicylate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EMAMI LIMITED

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Redness over the affected area - Sensitive skin For the temporary relief of minor aches and pains of muscles and joints associated with - Simple backache - Bruises - Strains - Arthritis - Sprains - Condition worsens or symptoms persist for more than 7 days - Symptoms clear up and occur again within a few days Topical analgesic

Authorization status:

OTC monograph not final

Summary of Product characteristics

ZANDU BALM- MENTHOL AND METHYL SALICYLATE OINTMENT
EMAMI 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._
----------
ACTIVE INGREDIENTS
Menthol 16%
Methyl salicaylate 10%
ASK A DOCTOR BEFORE USE IF YOU HAVE
Redness over the affected area
Sensitive skin
WHEN USING THIS PRODUCT
Use only as directed
Avoid contact with the eyes and mucous membranes.
Do not apply to wounds, damaged or irritated skin.
Do not bandage tightly
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION
If swallowed, get medical help or contact a poison control centre
immediately
IF PREGNANT OR BREAST FEEDING
If pregnant or breast feeding, or if you have sensitive skin, ask a
healthcare professional before use.
US ES
For the temporary relief of minor aches and pains of
muscles and joints associated with
Simple backache
Bruises
Strains
Arthritis
Sprains
QUES TIONS
Call (Emami customer care office Ph: 033 6613 6264)
STOP USE AND ASK A DOCTOR IF
Condition worsens or symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
OTHER INFORMATION
Store below 30°C (86° F) in a cool and dry place, away from direct
heat and sunlight.
WARNING
For external use only
INACTIVE INGREDIENTS
Light mineral oil, Microcrystalline wax, Paraffin
DIRECTIONS
Adults and children 12 years and older: Apply generously in a thin
layer on the affected area not
more than 3 to 4 times daily; massage gently on the affected area
Children under 12 years of age: consult a physician.
PURPOS E
Topical analgesic
DOSAGE & ADMINISTRATION
Dosage- Balm (Ointment)
Administration-Topical (For external use only)
PACKAGE LABEL
ZANDU BALM
menthol and methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:728 0 9 -10 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
METHYL SALICYLATE (UNI