Babyganics Cold Relief Chest Rub
FDA Label NDC 59062-1286

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kas Direct Llc Dba Babyganics for the product Babyganics Cold Relief Chest Rub (NDC 59062-1286). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if your child has, when using this product do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (18 g Tube Box)

Principal Display Panel (18 g Tube Box)

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