Label: NASAL DECONGESTANT- menthol, camphor,eucalyptus oil gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64092-403-04 - Packager: Great Lakes Wholesale, Marketing, and Sales, 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 August 5, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
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ACTIVE INGREDIENT
Active Ingredients Purpose
Menthol 1.0%........................................................................Decongestant
Camphor 4.7%......................................................................Decongestant
Eucalytus Oil 1.0%................................................................Decongentant
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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INSTRUCTIONS FOR USE
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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT
menthol, camphor,eucalyptus oil gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.17 in 110 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.1 in 110 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.1 in 110 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-403-04 110 g in 1 JAR; Type 0: Not a Combination Product 06/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2016 Labeler - Great Lakes Wholesale, Marketing, and Sales, INC (361925498) Registrant - Illinois Industrial Tool, Inc (628032898) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan chemical Products Co., Ltd. 530766098 manufacture(64092-403)