COUGH AND COLD THERAPY- camphor, menthol, eucalyptus oil ointment

Cough and Cold Therapy by

Drug Labeling and Warnings

Cough and Cold Therapy by is a Otc medication manufactured, distributed, or labeled by Everlaan Organics Inc, Cosmaceutical Research Laboratory Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Uses

Temporarily relieves cough associated with the common cold.

Warnings

For external use only

Do not use

• by mouth
• in nostrils

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).

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.

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.

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

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

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.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

maple organics

Cough & Cold Relief

Soothing & Calming Cough Relief Vapor Rub

Net Wt. 2oz / 56 g

INGREDIENTS AND APPEARANCE

COUGH AND COLD THERAPY 
camphor, menthol, eucalyptus oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83670-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.8 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.3 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY OIL (UNII: 8LGU7VM393)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83670-200-02	1 in 1 CARTON	09/14/2023
1		56 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/14/2023

Labeler - Everlaan Organics Inc (243282059)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(83670-200)