Indications and uses
temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older
temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older
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.
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.
Drug Facts
| 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 |
temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older
Do not use more than directed.
When using this product
Stop use and ask a physician or dentist if
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
citric acid, glycerin, purified water, sodium benzoate
call 1-800-344-7239 or visit our website at
www.gentlenaturals.com
Distributed by:
INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63736-318-24 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d4ac-621f-e053-dbdaa90a74ad | Gentle Naturals ® Homeopathic Teething Drops |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63736-318-24 | Gentle Naturals | 1 in 1 BOX | LIQUID | 1 | 1 | |
| 63736-318-24 | Gentle Naturals | 24 in 1 CASE | LIQUID | 24 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63736-318 | GENTLE NATURALS (MATRICARIA RECUTITA, TRIBASIC CALCIUM PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND DELPHINIUM STAPHISAGRIA SEED) LIQUID [INSIGHT PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20100903_ce73acdc-683a-4a86-aded-3a482e4c160c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Delphinium Staphisagria Seed | ACTIVE INGREDIENT | 00543AP1JV | 1 | |
| Magnesium Phosphate, Dibasic Trihydrate | ACTIVE INGREDIENT | HF539G9L3Q | 1 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| Potassium Phosphate, Dibasic | ACTIVE INGREDIENT | CI71S98N1Z | 1 | |
| Tribasic Calcium Phosphate | ACTIVE INGREDIENT | 91D9GV0Z28 | 1 | |
| Calcium Cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| Delphinium Staphisagria Seed | ACTIVE MOIETY | 00543AP1JV | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| Potassium Cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63736-318 | 63736-318-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Matricaria Recutita | G0R4UBI2ZZ | ACTIB |
| Tribasic Calcium Phosphate | 91D9GV0Z28 | ACTIB |
| Potassium Phosphate, Dibasic | CI71S98N1Z | ACTIB |
| Magnesium Phosphate, Dibasic Trihydrate | HF539G9L3Q | ACTIB |
| Delphinium Staphisagria Seed | 00543AP1JV | ACTIB |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / AURICULAR (OTIC) | 0.04 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| de833a93-7751-40ff-a620-ea7e5d4d8def | ce73acdc-683a-4a86-aded-3a482e4c160c | 2010-07-06 | Warnings | de833a93-7751-40ff-a620-ea7e5d4d8def ce73acdc-683a-4a86-aded-3a482e4c160c |
Adverse event summaries are temporarily unavailable. Other product information remains available.