Zen Sports Balm (Camphor, Eucalyptus Oil, Menthol, Methyl Salicylate) Cream [Zen Enterprises Llc] -

ZEN SPORTS BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [ZEN ENTERPRISES LLC]
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NDC	73048-000-01
Set ID	85ca4bbc-25b8-c688-e053-2991aa0a04e6
Category	HUMAN OTC DRUG LABEL
Packager	Zen Enterprises LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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ACTIVE INGREDIENT

Active Ingredients....................................Purpose

Camphor 11%............................................Topical Analgesic

Eucalyptus Oil 10%...................................Anti-Inflammatory

Menthol 8%...............................................Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%...Topical Analgesic
PURPOSE

Active Ingredients....................................Purpose

Camphor 11%............................................Topical Analgesic

Eucalyptus Oil 10%...................................Anti-Inflammatory

Menthol 8%...............................................Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%...Topical Analgesic
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a poison control center immediately.
INDICATIONS & USAGE
Uses

Temporary relives minor aches & pains related to
- headaches
- backaches
- joint and muscle pain
- cramps and spasms
- sprains and other sports related injuries
DOSAGE & ADMINISTRATION
Directions:
- Use only as directed
- Apply generously to affected area 3 to 4 times daily
- Children under 12, consult a doctor before use.
WARNINGS
CAUTIONS For external use only

When using this product
- discontinue use if excessive irritation of the skin develops
- avoid contact with eyes and mucus membranes
- do not bandage
- do not use with heating pad
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
- excessive skin irritation occurs
INACTIVE INGREDIENT

Inactive Ingredients

Narayani Oil, Clove Oil, Nutmeg Oil, Cassia Oil, Paraffin Wax, Cinnamon Oil, Peppermint Oil, White Petroleum Jelly, Borneol, Light Liquid Paraffin, Citronella Oil, Beeswax
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZEN SPORTS BALM
camphor, eucalyptus oil, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73048-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	11 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	10 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
NUTMEG OIL (UNII: Z1CLM48948)
CINNAMON OIL (UNII: E5GY4I6YCZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
BORNEOL (UNII: M89NIB437X)
PADANG CASSIA OIL (UNII: 0E15252LIW)
CITRONELLA OIL (UNII: QYO8Q067D0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73048-000-01	499 g in 1 JAR; Type 0: Not a Combination Product	04/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/15/2015

Labeler - Zen Enterprises LLC (063099830)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.Sankunni's Ayurvedic Research Foundation Private Limited		650517704	manufacture(73048-000)

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Medic

ZEN SPORTS BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [ZEN ENTERPRISES LLC]

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