Label: ZEN SPORTS BALM- camphor, eucalyptus oil, menthol, methyl salicylate cream
- NDC Code(s): 73048-000-01
- Packager: Zen Enterprises LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 8, 2021
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZEN SPORTS BALM
camphor, eucalyptus oil, menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73048-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73048-000-01 499 g in 1 JAR; Type 0: Not a Combination Product 04/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/15/2015 Labeler - Zen Enterprises LLC (063099830) Establishment Name Address ID/FEI Business Operations Dr.Sankunni's Ayurvedic Research Foundation Private Limited 650517704 manufacture(73048-000)
