NDC | 70146-007-01, 70146-007-02 |
Set ID | 38270beb-fa4a-67cf-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dr.Sankunni's Ayurvedic Research Foundation Private Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
WARNINGS
WARNINGS 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 tightly
- 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WOMENS SPORTS BALM
camphor, eucalyptus oil, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70146-007 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 Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) LIGHT MINERAL OIL (UNII: N6K5787QVP) YELLOW WAX (UNII: 2ZA36H0S2V) CLOVE OIL (UNII: 578389D6D0) NUTMEG OIL (UNII: Z1CLM48948) CHINESE CINNAMON OIL (UNII: A4WO0626T5) CINNAMON OIL (UNII: E5GY4I6YCZ) PEPPERMINT OIL (UNII: AV092KU4JH) BORNEOL (UNII: M89NIB437X) CITRONELLA OIL (UNII: QYO8Q067D0) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70146-007-01 5 g in 1 JAR; Type 0: Not a Combination Product 07/21/2016 2 NDC:70146-007-02 20 g in 1 JAR; Type 0: Not a Combination Product 07/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/21/2016 Labeler - Dr.Sankunni's Ayurvedic Research Foundation Private Limited (650517704) Establishment Name Address ID/FEI Business Operations Dr.Sankunni's Ayurvedic Research Foundation Private Limited 650517704 manufacture(70146-007)