Other
Drug Facts
Distributed by:
INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749
Gentle Naturals
FDA Label NDC 63736-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Gentle Naturals (NDC 63736-318). 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, otc - purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Chamomilla (Chamomile) 3X, 6X, 12X, 30X | pain and sensitivity of teething, calming |
| Calcarea Phosphorica (Calcium Phosphate) 6X | pain and sensitivity of teething |
| Kali Phosphoricum (Potassium Phosphate) 6X | pain in mouth and gums |
| Magnesia Phosphorica (Magnesium Phosphate) 6X | pain and sensitivity of teething |
| Staphysagria (Delphinium Staphisagria) 9X | pain and sensitivity of teething |
Uses
temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older
Otc - Do Not Use
Do not use more than directed.
Otc - When Using
When using this product
- fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician or dentist.
Otc - Stop Use
Stop use and ask a physician or dentist if
- sore mouth symptoms do not get better in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- children and infants over 4 months of age, place one half dropper (0.5mL) under the tongue every 2 hours. Once symptoms improve reduce to 4 times daily.
- for infants under 4 months of age, ask a physician or dentist.
Other Information
- Do not use if white neck band printed with "sealed for your protection" is broken or missing.
- Store tightly closed at room temperature 15°-25°C (59°-77°F).
- Keep carton for full drug facts.
Inactive Ingredients
citric acid, glycerin, purified water, sodium benzoate
Questions?
call 1-800-344-7239 or visit our website at www.gentlenaturals.com
Principal Display Panel - 29.6 Ml Bottle Carton
Gentle
Naturals®
Homeopathic
Teething Drops
Relieves Teething Pain
100% Natural with Chamomile
with No Known Side Effects
1 FL OZ (29.6 mL)
Principal Display Panel (29.6 mL Bottle Carton)
* Please review the disclaimer below.
