Drug Facts - Mentholatum Greaseless Vaporizing Cream

Drug Facts - Mentholatum Greaseless Vaporizing Cream
SPL v5
SPL
SPL Set ID 0142f7b1-5c21-464d-9143-846ec045b6ef
Route
TOPICAL
Published
Effective Date 2020-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (53 mg) Eucalyptus Oil (13 mg) Menthol, Unspecified Form (28 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Chlorphenesin Cyclomethicone 5 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Glycerin Hydrogenated Polybutene (1300 Mw) Hydrolyzed Wheat Protein (enzymatic; 3000 Mw) Magnesium Aluminum Silicate Type Ia Oleth-3 Phosphate Phenoxyethanol Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15

Description

Camphor 5.3% Eucalyptus oil 1.3% Menthol 2.8%

Purpose

Camphor – Cough suppressant / topical analgesic Eucalyptus oil – Cough suppressant Menthol – Cough suppressant / topical analgesic


Medication Information

Purpose

Camphor – Cough suppressant / topical analgesic

Eucalyptus oil – Cough suppressant

Menthol – Cough suppressant / topical analgesic

Description

Camphor 5.3% Eucalyptus oil 1.3% Menthol 2.8%

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • temporarily relieves cough to help you sleep
  • temporarily relieves minor aches and pains of muscles and joints
Warnings

For external use only

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or 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.
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • do not get into eyes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

  • cough lasts more than 7 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 or persist for more than 7 days or clear up and occur again within a few days
Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Directions
  • see important warnings under "When using this product"
  • adults and children 2 years and over:
  • for cough suppression -
    • rub a thick layer on the throat and chest
    • cover with a warm, dry cloth if desired
    • keep clothing loose about the throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily or as directed by a doctor
  • for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
  • children under 2 years : ask a doctor
Active Ingredients

Camphor 5.3%

Eucalyptus oil 1.3%

Menthol 2.8%

Inactive Ingredients

carbomer homopolymer, cetyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone crosspolymer-3, fragrance, glycerin, hydrogenated polyisobutene, hydrolyzed wheat protein/PVP crosspolymer, magnesium aluminum silicate, oleth-3 phosphate, phenoxyethanol, purified water, stearic acid, trolamine

Principal Display Panel
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • temporarily relieves cough to help you sleep
  • temporarily relieves minor aches and pains of muscles and joints
Purpose

Camphor – Cough suppressant / topical analgesic

Eucalyptus oil – Cough suppressant

Menthol – Cough suppressant / topical analgesic

Warnings

For external use only

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or 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.
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • do not get into eyes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

  • cough lasts more than 7 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 or persist for more than 7 days or clear up and occur again within a few days
Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Directions
  • see important warnings under "When using this product"
  • adults and children 2 years and over:
  • for cough suppression -
    • rub a thick layer on the throat and chest
    • cover with a warm, dry cloth if desired
    • keep clothing loose about the throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily or as directed by a doctor
  • for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
  • children under 2 years : ask a doctor
Active Ingredients (Active ingredients)

Camphor 5.3%

Eucalyptus oil 1.3%

Menthol 2.8%

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, cetyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone crosspolymer-3, fragrance, glycerin, hydrogenated polyisobutene, hydrolyzed wheat protein/PVP crosspolymer, magnesium aluminum silicate, oleth-3 phosphate, phenoxyethanol, purified water, stearic acid, trolamine

Principal Display Panel
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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