BABYGANICS COLD RELIEF CHEST RUB- menthol stick
KAS Direct LLC dba BabyGanics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BabyGanics® Cold Relief Chest Rub

Drug Facts

Active ingredient

Menthol 2.6%

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
suppresses the impulse to cough to help you sleep

Warnings

For external use only. Avoid contact with eyes.

Do not use

by mouth
in nostrils

Ask a doctor before use if your child has

persistent or chronic cough such as occurs with asthma
cough that occurs with too much 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 cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

see important warnings under "When using this product"
children 2 to under 12 years of age:
- apply a thick layer on chest & throat
- cover with a warm, dry cloth if desired
- keep clothing loose about throat/chest to help vapors reach the nose and mouth
- repeat up to 3 times per 24 hours or as directed by doctor
children under 2 years of age: ask a doctor

Other information

store at room temperature 59-77°F (15-25°C)
protect this product from excessive heat and direct sun

Inactive ingredients

beeswax, cedrus atlantica bark oil, eucalyptus globulas leaf oil, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, lavandula angustifolia (lavender) oil, olea europaea (olive) fruit oil, ricinus communis (castor) seed oil, rosmarinus officinalis (rosemary) leaf extract, silica, tocopherol

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 18 g Tube Box

Cold Relief Chest Rub
Cough Suppressant

Soft, Glide-On
Stick for
Hands-Free
Application

Provides
Comforting,
Soothing &
Calming Vapors

NO
Parabens, Phthalates,
Mineral Oil, Petrolatum,
Artificial Fragrance or Color

NET WT 0.64 OZ (18 g)

BABYGANICS COLD RELIEF CHEST RUB
menthol stick

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:59062-1286
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (MENTHOL)	MENTHOL	2.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX
CEDRUS ATLANTICA BARK OIL
EUCALYPTUS OIL
SOYBEAN OIL
SUNFLOWER OIL
LAVENDER OIL
OLIVE OIL
CASTOR OIL
ROSEMARY
SILICON DIOXIDE
TOCOPHEROL

#	Item Code	Package Description
Packaging
1	NDC:59062-1286-1	1 in 1 BOX
1		18 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	08/15/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 8/2013

Document Id: 03bab42c-9538-4f19-843f-539f4674f578

Set id: 35a39dac-7772-41f4-bd8a-9160e7776119

Version: 2

Effective Time: 20130819

KAS Direct LLC dba BabyGanics