Calendula, Comfrey - Aidance Skincare & Topical Solutions, LLC

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2015-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:51

Label at a glance#

ProductMom of 11 Kids No Time For Diaper Rash
Active ingredientCALENDULA OFFICINALIS FLOWER, COMFREY
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash.

Dosage and administration

Change wet and soiled diapers promptly. Cleanse the diaper area, and allow to dry. Apply cream as liberally as necessary.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula 1X HPUS, Comfrey 1X HPUS

Purpose

OTC - PURPOSE SECTION

Calendula - Healing agent / Skin protectant
Comfrey - Inflammatory relief

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash.

Warnings

WARNINGS SECTION

For external use only. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. When using this product avoid contact with eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Change wet and soiled diapers promptly. Cleanse the diaper area, and allow to dry. Apply cream as liberally as necessary.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Argan Oil, Beeswax (organic), Chamomile Oil, Coconut Oil, Cotton Seed Oil, Jojoba Seed Oil (golden), Kokum Butter, Magnesium Oxide, Olive Oil, Silver Oxide, Zinc Oxide.

PRINCIPAL DISPLAY PANEL - 165g Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mom of 11 Kids™

NO TIME FOR™
Diaper Rash

Safe & Natural is Finally Fast & Effective™
Net Wt. 5.9 oz. (165g)

Jar LabelJar Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24909-501-162020-01-31C16284748780-19d75b9d0-20e3-f424-e053-dadaa90a57ceDrug Facts
24909-501-862020-01-31C16284748780-19d75b9d0-20e3-f424-e053-dadaa90a57ceDrug Facts
24909-501-902020-01-31C16284748780-19d75b9d0-20e3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-501-16Mom of 11 Kids No Time For Diaper Rash165 g in 1 JAROINTMENT1651
24909-501-85Mom of 11 Kids No Time For Diaper Rash85 g in 1 TUBEOINTMENT851
24909-501-86Mom of 11 Kids No Time For Diaper Rash1 in 1 CANOINTMENT11
24909-501-90Mom of 11 Kids No Time For Diaper Rash90 g in 1 JAROINTMENT901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-501MOM OF 11 KIDS NO TIME FOR DIAPER RASH (CALENDULA, COMFREY) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1Legacy NDC, 4 package rows20150829_45390ff7-c75f-4f32-b53e-378d328b161d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD1
COMFREYACTIVE INGREDIENTD05HXK6R3G1
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD1
COMFREYACTIVE MOIETYD05HXK6R3G1
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X1
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A91
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
COTTONSEED OILINACTIVE INGREDIENTH3E878020N1
GARCINIA INDICA FRUITINACTIVE INGREDIENT0Q3R71D98M1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6T1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24909-50124909-501-16, 24909-501-90, 24909-501-85, 24909-501-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
COTTONSEED OILCOTTONSEED OILH3E878020NINJECTION / INTRAMUSCULAR1084 mgExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT, AUGMENTED / TOPICAL429 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, EXTENDED RELEASE / ORAL25.74 mgExact identifier — unii candidate
9 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NTABLET / ORAL0.16 mgExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GGUM, CHEWING / BUCCAL173 mgExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, EXTENDED RELEASE / ORAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
9 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE / ORAL79 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, DELAYED RELEASE / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FSUPPOSITORY / RECTAL265 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, DELAYED RELEASE / ORAL368 mgExact identifier — unii candidate
9 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NCAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
15 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET / ORAL63 mgExact identifier — unii candidate
9 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NINJECTION, SOLUTION / INTRAMUSCULAR1120 mgExact identifier — unii candidate
5 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, FILM COATED / ORAL80 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET / SUBLINGUAL15 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FLOTION / TOPICAL1 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NSPRAY, METERED / NASAL1.33 mg/0.1mlExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE / ORAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWER

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.