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Vapor Rub

Vapor Rub

Approved
Approval ID

39190f9f-8a5a-e4d8-e063-6294a90a57dd

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 4, 2025

Manufacturers
FDA

Neilmed Pharmaceuticals Inc.

DUNS: 799295915

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cough Suppressant

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13709-336
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cough Suppressant
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 4, 2025
FDA Product Classification

INGREDIENTS (8)

MENTHOLActive
Quantity: 0.026 g in 1 g
Code: L7T10EIP3A
Classification: ACTIB
TURPENTINE OILInactive
Code: C5H0QJ6V7F
Classification: IACT
CEDAR LEAF OILInactive
Code: BJ169U4NLG
Classification: IACT
EUCALYPTUS OILActive
Quantity: 0.012 g in 1 g
Code: 2R04ONI662
Classification: ACTIB
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
NUTMEG OILInactive
Code: Z1CLM48948
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 0.048 g in 1 g
Code: 5TJD82A1ET
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/4/2025

Vapor Rub CartonVapor Rub Jar

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/4/2025

Directions

  • See important warnings under “when using this product”
  • Adults and children 2 years and over:
  • Rub a thick layer on the front of the neck and chest for cough, or rub on sore or aching muscles or joints
  • Cover with a warm, dry cloth if desired
  • Clothing should be left loose over the throat and chest to help vapors reach the nose and mouth
  • Use up to 3 times daily or as directed by a doctor
  • Children under 2 years: ask a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/4/2025

Drug Facts

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/4/2025

Purpose

Cough suppressant / topical analgesic

Cough suppressant

Cough suppressant / topical analgesic

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/4/2025

Uses

  • When applied to the throat and chest, temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • When applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints

WARNINGS SECTION

LOINC: 34071-1Updated: 7/4/2025

Warnings

For external use only

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/4/2025

Ask a doctor before use if you have

  • Cough that occurs with too much phlegm (mucus)
  • Chronic or persistent cough, such as occurs with smoking, asthma or emphysema

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/4/2025

When using this product

  • Do not heat • Do not microwave
  • Do not add to hot water or an container where heating water.
  • May cause splattering and result in burns
  • Do not take by mouth or place in nostrils
  • Do not get into eyes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/4/2025

Stop use and ask a doctor if

  • Cough lasts more than 5 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
  • Muscle aches and pains worsen, persist for more than 5 days, or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/4/2025

If pregnant or breastfeeding,

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/4/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/4/2025

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/4/2025

Inactive Ingredients

Cedarleaf oil, Nutmeg oil, Petrolatum, Thymol, & Turpentine oil

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Vapor Rub - FDA Drug Approval Details