SPL v3
SPL
SPL Set ID 09e4a36b-020a-c5b1-e063-6394a90a3e31
Route
TOPICAL
Published
Effective Date 2022-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Salicylic Acid Camphor (synthetic)
Inactive Ingredients
Microcrystalline Wax Water Mineral Oil Cetyl Alcohol Polyoxyl 20 Cetostearyl Ether Methylisothiazolinone Polysorbate 80 Trolamine Isopropyl Alcohol Fd&c Blue No. 1 Carbomer Homopolymer, Unspecified Type Turpentine Eucalyptol Petrolatum Chamomile

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01
Description

Directions Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.

Medication Information

Warnings and Precautions
  • For external use only; avoid contact with eyes
  • Ask a doctor before if you have: sensitive skin

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin

When using this product

  • Avoid contact with the ayes or muccus membranes
  • Wash hands after use with cool water
  • Do not microwave

Stop use and ask a doctor if:

  • Cough occurs with too much mucus (phlegm), or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Indications and Usage

Directions

Adults and children 2 years of age and older:

Rub a thick layer well over throat and chest

Use 3 to 4 times daily

Keep clothes loose about throat and chest to help vapors reach nose and mouth

For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily

Children under 2 years: do not use.

Dosage and Administration

Directions

  • Adults and children 2 years of age and older:
  • Rub a thick layer well over throat and chest
  • Use 3 to 4 times daily
  • Keep clothes loose about throat and chest to help vapors reach nose and mouth
  • For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily
  • Children under 2 years: do not use.
Description

Directions Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.

1594

1595

1598

1599

1600

1601

1602

1605

1606

1609

1610

1611

1612

1620

Section 50565-1

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 51727-6

T

Section 53413-1

[email protected]

Section 55105-1

When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with common cold.

Section 55106-9

Mentol, Camphor (synthetic)

Structured Label Content

1594

1595

1598

1599

1600

1601

1602

1605

1606

1609

1610

1611

1612

1620

Indications and Usage (34067-9)

Directions

Adults and children 2 years of age and older:

Rub a thick layer well over throat and chest

Use 3 to 4 times daily

Keep clothes loose about throat and chest to help vapors reach nose and mouth

For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily

Children under 2 years: do not use.

Dosage and Administration (34068-7)

Directions

  • Adults and children 2 years of age and older:
  • Rub a thick layer well over throat and chest
  • Use 3 to 4 times daily
  • Keep clothes loose about throat and chest to help vapors reach nose and mouth
  • For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily
  • Children under 2 years: do not use.
Warnings and Precautions (34071-1)
  • For external use only; avoid contact with eyes
  • Ask a doctor before if you have: sensitive skin

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin

When using this product

  • Avoid contact with the ayes or muccus membranes
  • Wash hands after use with cool water
  • Do not microwave

Stop use and ask a doctor if:

  • Cough occurs with too much mucus (phlegm), or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Section 50565-1 (50565-1)

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

T

Section 53413-1 (53413-1)

[email protected]

Section 55105-1 (55105-1)

When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with common cold.

Section 55106-9 (55106-9)

Mentol, Camphor (synthetic)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:20.416346 · Updated: 2026-03-14T23:12:34.529887