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

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

Other information

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

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)

Principal Display Panel - 18 g Tube Box
BABYGANICS COLD RELIEF CHEST RUB 
menthol stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1286
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1286-11 in 1 BOX08/15/2013
118 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/15/2013
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 1/2018
Document Id: af8ec19d-7856-4d22-8ea0-a5eee0b84847
Set id: 35a39dac-7772-41f4-bd8a-9160e7776119
Version: 4
Effective Time: 20180123
 
KAS Direct LLC dba BabyGanics