Label: MENTHOL CAMPHOR COUGH SUPPRESSANT RUB (camphor- natural and menthol, unspecified form ointment
- NDC Code(s): 72342-010-16
- Packager: J.R. Watkins, LLC.
- 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 August 30, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only.
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage tightly
- get in eyes.
Do not use
- for persistent or chronic cough as occurs with smoking, asthma, or emphysema
- if cough is accompanied by excessive phlegm unless directed by a physician.
- near an open flame
- by adding to hot water
- in a microwave oven. Improper use may cause the mixture to splatter and cause burns.
Discontinue use and consult a physician if cough or other symptoms
- are accompanied by fever, rash or persistent headache
- persist more than 7 days
- clear up then recur within a few days
For adults and children 2 years and older:
- aches, pains or itching; apply to affected area not more than 3-4 times daily.
- cough as occurs with cold; apply thick layer to throat and chest. Area of application may be covered with a warm, dry cloth. Clothing should be left loose about the throat and chest to help the vapors rise to reach nose and mouth. Applications may be repeated up to 3 times or as directed by physician. For children under 2 years of age: Consult a physician.
- Other information
- Inactive ingredients
- FOR QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL - 116 g Jar Box
INGREDIENTS AND APPEARANCE
MENTHOL CAMPHOR COUGH SUPPRESSANT RUB
camphor (natural) and menthol, unspecified form ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72342-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 5.3 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.8 g in 100 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72342-010-16 1 in 1 BOX 09/01/2019 1 116 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2019 Labeler - J.R. Watkins, LLC. (081071049)