Inflammation Therapy

Manufacturer: Sundial Group LLC
Effective date: 2013-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:40:22

Label at a glance#

ProductInflammation Therapy

Active ingredientCALENDULA OFFICINALIS FLOWERING TOP

Label structure9 sections

Contacts and useful links#

PhoneLabel contact631-842-8800

Websitewww.sheamoisture.com

www.SheaMoisture.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Calendula Officinalis Extract - 1X	Reduces inflammation

INDICATIONS & USAGE SECTION

Uses: Reduces skin inflammation.

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Warnings:For external use only. When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

SPL UNCLASSIFIED SECTION

Other information: For use on mild skin inflammation, or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Sodium Palmate, Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Coconut Acid, Palmitic Acid, Sodium Chloride, Butyrospermum Parkii (Shea) Butter*, Titanium Dioxide (CI 77891), Aspalathus Linearis Leaf, Cannabis Sativa Seed Oil, Yellow 10 (CI 47005), Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Melia Azadirachta Seed Oil, Red 4 (CI 14700), Green 3 (CI 42053).

*Certified Organic Ingredient

OTC - QUESTIONS SECTION

Questions or comments? 631-842-8800 or visit www.SheaMoisture.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Boxes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58666-3121-6	2024-10-21	C162847	48780-1	9d75b9cf-e6ab-f424-e053-dadaa90a57ce	Inflammation Therapy
58666-3121-6	2020-01-31	C162847	48780-1	9d75b9cf-e6ab-f424-e053-dadaa90a57ce	Inflammation Therapy

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	1
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	1
ASPALATHUS LINEARIS LEAF	INACTIVE INGREDIENT	H7UGK1GJCU	1
AZADIRACHTA INDICA SEED OIL	INACTIVE INGREDIENT	4DKJ9B3K2T	1
CANNABIS SATIVA SEED	INACTIVE INGREDIENT	QE567Z26NG	1
COCONUT ACID	INACTIVE INGREDIENT	40U37V505D	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
ETIDRONATE TETRASODIUM	INACTIVE INGREDIENT	CZZ9T1T1X4	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM PALM KERNELATE	INACTIVE INGREDIENT	6H91L1NXTW	1
SODIUM PALMATE	INACTIVE INGREDIENT	S0A6004K3Z	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Inflammation Therapy
CALENDULA OFFICINALIS FLOWERING TOP
SODIUM PALMATE
SODIUM PALM KERNELATE
WATER
GLYCERIN
COCONUT ACID
PALMITIC ACID
SODIUM CHLORIDE
SHEA BUTTER
TITANIUM DIOXIDE
ASPALATHUS LINEARIS LEAF
CANNABIS SATIVA SEED
D&C YELLOW NO. 10
EDETATE SODIUM
ETIDRONATE TETRASODIUM
FERRIC OXIDE RED
AZADIRACHTA INDICA SEED OIL
FD&C RED NO. 4
FD&C GREEN NO. 3

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58666-3121	58666-3121-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALENDULA OFFICINALIS FLOWERING TOP	18E7415PXQ	ACTIB
SODIUM PALMATE	S0A6004K3Z	IACT
SODIUM PALM KERNELATE	6H91L1NXTW	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
COCONUT ACID	40U37V505D	IACT
PALMITIC ACID	2V16EO95H1	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SHEA BUTTER	K49155WL9Y	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ASPALATHUS LINEARIS LEAF	H7UGK1GJCU	IACT
CANNABIS SATIVA SEED	QE567Z26NG	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
EDETATE SODIUM	MP1J8420LU	IACT
ETIDRONATE TETRASODIUM	CZZ9T1T1X4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
AZADIRACHTA INDICA SEED OIL	4DKJ9B3K2T	IACT
FD&C RED NO. 4	X3W0AM1JLX	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT

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 6 · 334 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SHAMPOO / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
24b208f5-5faf-af2a-e063-6394a90ad4e0			8f7c31e9-c389-4b23-8166-2f05e294b614	2024-10-17	Warnings	Exact identifier spl set id: 8f7c31e9-c389-4b23-8166-2f05e294b614

Reported adverse events (FAERS/openFDA)#

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