BABYGANICS COLD RELIEF CHEST RUB- menthol stick

BabyGanics Cold Relief Chest Rub by

Drug Labeling and Warnings

BabyGanics Cold Relief Chest Rub by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 18 g Tube Box

babyganics®

cold relief chest rub

with natural menthol ∙ cough suppressant
non-allergenic ∙ pediatrician &
dermatologist tested

no: parabens, phthalates, mineral oil,
petrolatum, artificial fragrances or dyes

0.64 OZ(18g)

INGREDIENTS AND APPEARANCE

BABYGANICS COLD RELIEF CHEST RUB 
menthol stick

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
CASTOR OIL (UNII: D5340Y2I9G)
ROSEMARY (UNII: IJ67X351P9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1286-1	1 in 1 BOX	08/15/2013
1		18 g in 1 TUBE; 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	08/15/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)