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

Cough and Cold Therapy For Kids by

Drug Labeling and Warnings

Cough and Cold Therapy For Kids 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 4.7%

Organic Menthol 2.6%

Organic Eucalyptus Oil 1.2%

Purpose

Organic Camphor 4.7%......................Topical Antitussive

Organic Menthol 2.6%........................Topical Antitussive

Organic Eucalyptus Oil 1.2%..............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 asthma 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 fevrer, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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"

Children 2 years and older:

• rub on the throat and chest in a thick layer
• 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

Children under 2 years of age: Ask a doctor.

Other information

Tamper-evdent. Ensure seal is intact before use.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

maple organics

Cough & Cold Therapy For Kids

Soothing & Calming Cough Suppressant

Net Wt. 2 oz / 56 g

INGREDIENTS AND APPEARANCE

COUGH AND COLD THERAPY FOR KIDS 
camphor, menthol, eucalyptus oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83670-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4.7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83670-201-02	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(83670-201)