Label: COLD RUB- camphor eucalyptus oil menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 51444-001-38 - Packager: JMD All Star Impex Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 30, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- See important warnings under "When using product"
- Children under 2 years of age, ask a doctor before using the product
- Adults
and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing
loose. Repeat up to 3 times daily
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD RUB
camphor eucalyptus oil menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51444-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 4.8 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.8 g in 100 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG (UNII: AEE24M3MQ9) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE (UNII: XJ6RUH0O4G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51444-001-38 108 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/15/2010 Labeler - JMD All Star Impex Inc. (962316662) Establishment Name Address ID/FEI Business Operations Steller Mercantile Pvt.Ltd. 650493005 manufacture