Label: BABYGANICS COLD RELIEF CHEST RUB- menthol stick
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 23, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only. Avoid contact with eyes.
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
- 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.
- 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
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
- PRINCIPAL DISPLAY PANEL - 18 g Tube Box
INGREDIENTS AND APPEARANCE
BABYGANICS COLD RELIEF CHEST RUB
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)