SWEET COMFORT- menthol oil

Sweet Comfort by

Drug Labeling and Warnings

Sweet Comfort by is a Otc medication manufactured, distributed, or labeled by Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

DRUG FACTS Active ingredient

Menthol 2.76%

PURPOSE

Purpose Antitussive (Cough Suppressant)

Uses Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.  Supresses your cough to help you get to sleep. 

Warnings

For external use only.

Do not take by mouth or place in nostrils

Flammable: Keep away from fire or flame.

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus).
• epilepsy

When using this product, do not

• heat
• microwave
• use near an open flame
• add to hot water or any container where heating water.  May cause splattering and result in burns.
• sun tan/use tanning beds for 3-4 days after use.

Stop use and ask a doctor if

cough 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 breast-feeding,

do not use this product.

Keep out of reach of children. 

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

Directions

• See important warnings under 'When using this product'.
• Adults and children 12 years of age 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

DOSAGE & ADMINISTRATION

• use up to three times daily or as directed by a doctor.
• Children under 12 years of age: ask a doctor. 

Other information

• Close container tightly and store at room temperature away from heat.

Inactive ingredients

Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, pine needle oil, and prunus armeniaca (apricot) kernel oil. 

Questions?

1-877-275-7253

Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made in Canada

SPL UNCLASSIFIED SECTION

Do not use if security seal around bottle is broken or missing.

Sweet Comfort 10 ml

SKU 431701

Sweet Comfort 6 ml

Lift Here

SKU 432301

DISPOSAL AND WASTE HANDLING

We support recycling. Please recycle where possible.

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 10 ml

sweet comfort

Saje® Natural Wellness

Sweet Comfort

Antitussive (Cough Suppressant) Oil Blend Rub

For external use only.

0.34 fl. oz. | 10 ml

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 6 ml

sweet comfort

Saje® Natural Wellness

Sweet Comfort

Antitussive (Cough Suppressant) Oil Blend Rub

For external use only.

0.2 fl. oz. | 6 ml

INGREDIENTS AND APPEARANCE

SWEET COMFORT 
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	24.56 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON OIL (UNII: I9GRO824LL)
TEA TREE OIL (UNII: VIF565UC2G)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
APRICOT KERNEL OIL (UNII: 54JB35T06A)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-004-04	1 in 1 BOX	10/16/2016
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 69204-004-05	1 in 1 BOX	10/16/2016
2		6 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/16/2016

Labeler - Natures Formulae Health Products Ltd. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-004)