Label: VAPOUR RUB- vapor rub ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69728-0030-1, 69728-0030-2 - Packager: PROSANA DISTRIBUCIONES, S.A. DE C.V.
- 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 1, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Store
- Inactive ingredients
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Directions-See important warnings under "When Using This Product"
Directions-See important warnings under "When Using This Product"
For External use only
For external use only; avoid contact with eyes
Do not use
-by mouth
-in nostrils
-on wounds
or damaged skin
-with light bandages
Ask a Doctor
Ask a doctor before use if you have
-cough that occurs with too much phlegm
-persistant or chronic cough, such as occurs with smoking, asthma or emphysema
When using this product
When using this product do not:
-heat-microwave-add to hot water or any container where heating water. May cause splattering and result in burns.
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Directions
Directions-see important warnings under "when using this product"
-adults and children 2 years and over
-for cough suppression
-rub a thick layer on throat and chest
-cover with a warm cloth if desired
-keep clothing loose around throat and chest to help vapors reach the nose and mucus
-use up to three times a day or as directed by a doctor
-for muscle/joint aches and pains apply to affected area no more than 3 to 4 times daily
-children under 2 years do not use
- If pregnant
- Children
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Warning
Failure to follow these warnings could result in serious consequences
For external use only, avoid contact with eyes
Do not use-by mouth-in nostrils-on wounds of damaged skin-with tight bandages
Ask a doctor before use if you have
-cough that occurs with too much phlegm (mucus)
-persistent or chronic cough such as occurs with smoking, asthma or emphysema
When using this product, do not
-heat-microwave-add to hot water or any container where heating water. May cause splattering and result in burns
Stop use and ask a doctor if
-musche aches and pains worsen or persist for more than 7 days or clear up and accur again after a few days
-cough persit for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition
- Principal display 100 g
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INGREDIENTS AND APPEARANCE
VAPOUR RUB
vapor rub ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69728-0030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.8 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 g in 100 g Inactive Ingredients Ingredient Name Strength THYMOL (UNII: 3J50XA376E) 1.2 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) 87.3 g in 100 g CEDAR LEAF OIL (UNII: BJ169U4NLG) 1.2 g in 100 g NUTMEG OIL (UNII: Z1CLM48948) 1.2 g in 100 g TURPENTINE OIL (UNII: C5H0QJ6V7F) 0.5 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69728-0030-2 1 in 1 BOX 04/05/2017 1 NDC:69728-0030-1 100 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 final part341 04/05/2017 Labeler - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867) Registrant - PROSANA DISTRIBUCIONES, S.A. DE C.V. (816197867) Establishment Name Address ID/FEI Business Operations PROSANA DISTRIBUCIONES, S.A. DE C.V. 816197867 manufacture(69728-0030)
