FDA Label for Babyganics Cold Relief Chest Rub
View Indications, Usage & Precautions
Babyganics Cold Relief Chest Rub Product Label
The following document was submitted to the FDA by the labeler of this product Kas Direct Llc Dba Babyganics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801
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.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
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
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)
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