NDC | 69274-003-08, 69274-003-09, 69274-003-10, 69274-003-11, 69274-003-12, 69274-003-13, 69274-003-14 |
Set ID | d1ebac26-e9e1-4faa-9609-5feaabadb9aa |
Category | HUMAN OTC DRUG LABEL |
Packager | FOUR SEASONS TRADING INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions: see important warnings under “When using this product”
adults and children 2 years and over:
- rub a thick layer on chest and throat
- keep clothing loose around chest/throat to help vapors reach the nose/mouth
- use up to 3 times daily as directed by doctor
children under 2 years of age: ask a doctor
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VAPORIZING CHEST RUB
menthol and camphor and eucalyptus oil gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69274-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.7 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) NUTMEG OIL (UNII: Z1CLM48948) TURPENTINE OIL (UNII: C5H0QJ6V7F) THYMOL (UNII: 3J50XA376E) CEDAR LEAF OIL (UNII: BJ169U4NLG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69274-003-08 50 g in 1 BOTTLE, PLASTIC 2 NDC:69274-003-09 56.6 g in 1 BOTTLE, PLASTIC 3 NDC:69274-003-10 100 g in 1 BOTTLE, PLASTIC 4 NDC:69274-003-11 113 g in 1 BOTTLE, PLASTIC 5 NDC:69274-003-12 150 g in 1 BOTTLE, PLASTIC 6 NDC:69274-003-13 170 g in 1 BOTTLE, PLASTIC 7 NDC:69274-003-14 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/25/2014 Labeler - FOUR SEASONS TRADING INC (169331464) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(69274-003)