Vapor Rub

Vapor Rub
SPL v2
SPL
SPL Set ID 39190f9f-8a5a-e4d8-e063-6294a90a57dd
Route
TOPICAL
Published
Effective Date 2025-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.026 g) Camphor (synthetic) (0.048 g) Eucalyptus Oil (0.012 g)
Inactive Ingredients
Paraffin Turpentine Oil Cedar Leaf Oil Thymol Nutmeg Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-04

Description

Active ingredients Camphor 4.8% Eucalyptus oil 1.2% Menthol 2.6%

Purpose

Cough suppressant / topical analgesic Cough suppressant Cough suppressant / topical analgesic


Medication Information

Purpose

Cough suppressant / topical analgesic

Cough suppressant

Cough suppressant / topical analgesic

Description

Active ingredients Camphor 4.8% Eucalyptus oil 1.2% Menthol 2.6%

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
Section 51945-4

Warnings

For external use only

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.
Drug Facts

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

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.

Questions?

Call 1 (877) 477-8633

Other Information

Store at room temperature

Inactive Ingredients

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

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
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.
If Pregnant Or Breastfeeding,

ask a health professional before use

Keep Out of Reach of Children.

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

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

Structured Label Content

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
Section 51945-4 (51945-4)

Purpose

Cough suppressant / topical analgesic

Cough suppressant

Cough suppressant / topical analgesic

Warnings

For external use only

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.
Drug Facts

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

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.

Questions?

Call 1 (877) 477-8633

Other Information

Store at room temperature

Inactive Ingredients

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

When Using This Product (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
Stop Use and Ask A Doctor If (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.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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