Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: 100 gm contains: 50 gm Calendula 1X
OTC - PURPOSE SECTION
Uses: Temporary relief of minor cuts and wounds.
Calendula 10%
- Manufacturer
- Uriel Pharmacy Inc.
- Effective date
- 2024-03-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:26:24
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Directions: FOR TOPICAL USE ONLY.
Warnings
WARNINGS SECTION
Warnings: FOR EXTERNAL USE ONLY. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Apply to skin as needed. Under age 2: Consult a doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Spring water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate, Lavender oil, Sodium hydroxide, Sorbic acid, Tea tree oil, Grapefruit seed extract "prepared using rhythmical processes"
OTC - QUESTIONS SECTION
Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 shopuriel.com Lot#
Label Images#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-4165-5 | Calendula 10% | 60 g in 1 TUBE | GEL | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-4165 | CALENDULA 10% GEL [URIEL PHARMACY INC.] | 2 | Legacy NDC, 1 package rows | 20240319_c19b1db8-df51-e8fc-e053-2a95a90aee03.zip |
Products#
- Calendula 10%
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-4165 | 48951-4165-5 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM ALGINATE | C269C4G2ZQ | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| LAVENDER OIL | ZBP1YXW0H8 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| CITRUS PARADISI SEED | 12F08874Y7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
Complete SPL Sections#
INDICATIONS & USAGE SECTION
Directions: FOR TOPICAL USE ONLY.
DOSAGE & ADMINISTRATION SECTION
Apply to skin as needed. Under age 2: Consult a doctor.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: 100 gm contains: 50 gm Calendula 1X
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Spring water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate, Lavender oil, Sodium hydroxide, Sorbic acid, Tea tree oil, Grapefruit seed extract "prepared using rhythmical processes"
OTC - PURPOSE SECTION
Uses: Temporary relief of minor cuts and wounds.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
WARNINGS SECTION
Warnings: FOR EXTERNAL USE ONLY. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.
OTC - QUESTIONS SECTION
Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 shopuriel.com Lot#