NDC | 52000-012-08, 52000-012-09, 52000-012-10, 52000-012-11, 52000-012-12, 52000-012-13, 52000-012-14 |
Set ID | d1b1c91e-d101-48bd-b4e0-ed8b3706f990 |
Category | HUMAN OTC DRUG LABEL |
Packager | Universal Distribution Center LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- adults and children 2 years and over
- rub a thick layer on chest and throat or rub on sore aching muscles
-
keep clothing loose around chest/throat to help vapors reach the nose/mouth
- repeat up to 3 times per 24 hours or as directed by doctor
- do not use on children under 2 years unless directed by 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:52000-012 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 CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE OIL (UNII: C5H0QJ6V7F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-012-08 50 g in 1 BOTTLE, PLASTIC 2 NDC:52000-012-09 56.6 g in 1 BOTTLE, PLASTIC 3 NDC:52000-012-10 100 g in 1 BOTTLE, PLASTIC 4 NDC:52000-012-11 113 g in 1 BOTTLE, PLASTIC 5 NDC:52000-012-12 150 g in 1 BOTTLE, PLASTIC 6 NDC:52000-012-13 170 g in 1 BOTTLE, PLASTIC 7 NDC:52000-012-14 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/15/2013 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52000-012) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-012)