Cough & Cold Relief

Cough & Cold Relief
SPL v3
SPL
SPL Set ID 088be461-7afc-586a-e063-6294a90a700b
Route
TOPICAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.8 g) Eucalyptus Oil (1.3 g) Camphor (natural) (5 g)
Inactive Ingredients
Rosemary Oil Shea Butter Coconut Oil Yellow Wax Olive Oil Jojoba Oil .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-14

Description

Organic Camphor 5.0% Organic Menthol 2.8% Organic Eucalyptus Oil 1.3%

Purpose

Organic Camphor 5.0%.......................Topical Antitussive Organic Menthol 2.8%.........................Topical Antitussive Organic Eucalyptus Oil 1.3%...............Topical Antitussive


Medication Information

Purpose

Organic Camphor 5.0%.......................Topical Antitussive

Organic Menthol 2.8%.........................Topical Antitussive

Organic Eucalyptus Oil 1.3%...............Topical Antitussive

Description

Organic Camphor 5.0% Organic Menthol 2.8% Organic Eucalyptus Oil 1.3%

Uses

Temporarily relieves cough associated with the common cold.

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7

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.
Section 50569-3

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1

Do not use

  • by mouth
  • in nostrils
Section 51945-4

maple organics

Cough & Cold Relief

Soothing & Calming Cough Relief Vapor Rub

Net Wt. 2oz / 56 g

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

Directions

See important warnings under "When using this product"

Adults:

  • rub on the throat, chest and/or bottom of feet
  • massage into skin until solution vanishes
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by a doctor
Other Information

Tamper-evident. Ensure seal is intact before use.

Active Ingredients

Organic Camphor 5.0%

Organic Menthol 2.8%

Organic Eucalyptus Oil 1.3%

Inactive Ingredients

Organic Beeswax, Organic Coconut Oil, Organic Jojoba Oil, Organic Olive Oil, Organic Rosemary Oil, Organic Shea Butter, Vitamin E.


Structured Label Content

Uses

Temporarily relieves cough associated with the common cold.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7 (50567-7)

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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1 (50570-1)

Do not use

  • by mouth
  • in nostrils
Section 51945-4 (51945-4)

maple organics

Cough & Cold Relief

Soothing & Calming Cough Relief Vapor Rub

Net Wt. 2oz / 56 g

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Organic Camphor 5.0%.......................Topical Antitussive

Organic Menthol 2.8%.........................Topical Antitussive

Organic Eucalyptus Oil 1.3%...............Topical Antitussive

Warnings

For external use only

Directions

See important warnings under "When using this product"

Adults:

  • rub on the throat, chest and/or bottom of feet
  • massage into skin until solution vanishes
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by a doctor
Other Information (Other information)

Tamper-evident. Ensure seal is intact before use.

Active Ingredients (Active ingredients)

Organic Camphor 5.0%

Organic Menthol 2.8%

Organic Eucalyptus Oil 1.3%

Inactive Ingredients (Inactive ingredients)

Organic Beeswax, Organic Coconut Oil, Organic Jojoba Oil, Organic Olive Oil, Organic Rosemary Oil, Organic Shea Butter, Vitamin E.


Advanced Ingredient Data


Raw Label Data

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