Label: HEALTH SMART VAPORIZING CHEST RUB- menthol and camphor and eucalyptus oil gel
- NDC Code(s): 30400-702-01, 30400-702-02, 30400-702-03
- Packager: Jell Pharmaceuticals Pvt Ltd.
- 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 February 15, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
HEALTH SMART VAPORIZING CHEST RUB
menthol and camphor and eucalyptus oil gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30400-702 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:30400-702-01 50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2022 2 NDC:30400-702-02 56.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2022 3 NDC:30400-702-03 100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/15/2022 Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211) Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(30400-702)