ZANDU BALM- menthol and methyl salicylate ointment

ZANDU BALM by

Drug Labeling and Warnings

ZANDU BALM by is a Otc medication manufactured, distributed, or labeled by EMAMI LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Uses

For the temporary relief of minor aches and pains of
muscles and joints associated with

• Simple backache
• Bruises
• Strains
• Arthritis
• Sprains

Questions

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.

Purpose

Topical analgesic

Dosage & Administration

Dosage- Balm (Ointment)

Administration-Topical (For external use only)

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

ZANDU BALM 
menthol and methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72809-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	160 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72809-103-11	1 in 1 BOX	11/21/2019
1		7.74 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 72809-103-12	1 in 1 BOX	11/21/2019
2		21.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/21/2019

Labeler - EMAMI LIMITED (860316299)