Label: 4OZ MEDICATED CHEST RUB- menthol, camphor, eucalyptus oil ointment
- NDC Code(s): 81984-099-01
- Packager: Pride Products Corporation
- 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.
Updated December 20, 2017
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- ACTIVE INGREDIENTS
- If pregnant or breast feeding,
- OTHER SAFETY INFORMATION
- Consult a physician before use.
- Keep out of reach of children.
Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. children under 2 years of age, consult your physician.
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
4OZ MEDICATED CHEST RUB
menthol, camphor, eucalyptus oil ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81984-099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.7 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:81984-099-01 110 g in 1 JAR; Type 0: Not a Combination Product 12/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/01/2017 Labeler - Pride Products Corporation (112666285) Registrant - Pride Products Corporation (112666285) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(81984-099)