Wound Healing

Manufacturer: Active Release Techniques | Leo Desilets maitre herboriste Inc/Facotek Packaging
Effective date: 2011-03-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:03:08

Label at a glance#

ProductWound Healing

Active ingredientCALENDULA OFFICINALIS FLOWERING TOP

Label structure13 sections

Contacts and useful links#

PhoneLabel contact1-888-788-2320

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calendula (Calendula Officinalis)

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Topical relief for:

wound healing
cuts, scrapes and abrasions
minor burns, sunburns

as per Homeopathic Materia Medica

WARNINGS SECTION

for external use only

OTC - DO NOT USE SECTION

Do not use:

in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor
this product if you are allergic to any of the ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

OTC - STOP USE SECTION

Stop use and ask a doctor:

if condition persists or gets worse
if a rash or other irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

clean the affected area
apply a small amount of this product on the area 1 to 3 times daily
may be covered with a bandage

INACTIVE INGREDIENT SECTION

Argania Spinosa Kernel Oil, Betula Alba Bark Extract, Cetearyl Olivate, Chlorphenesin, Citric Acid, Copernicia Cerifera (Carnauba) Wax, Dromiceius, Ethoxydiglycol, Glycerin, Hippophae Rhamnoides Oil, Isopropyl Palmitate, Leptospermum Scoparium Oil, Porphyridium Cruentum Extract, Potassium Citrate, Rutin, Sambucus Nigra Flower Extract, Scrophularia Nodosa Extract, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Water/Aqua, Xanthan Gum

OTC - QUESTIONS SECTION

Questions or Comments?

1-888-788-2320 Monday through Friday, 9am-5pm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Cream for Wound Healing
Natural Active Ingredient
Non-Greasy

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76029-003-35	2019-10-29	C162847	48780-1	960f7f55-d7e7-8e05-e053-dbdaa90a074a	b4be80a4-c888-44e4-9095-20817daaf7d8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76029-003-35	Wound Healing	35 g in 1 BOTTLE	CREAM	35		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76029-003	WOUND HEALING (CALENDULA OFFICINALIS) CREAM [ACTIVE RELEASE TECHNIQUES]	2	Legacy NDC, 1 package rows	20110420_b4be80a4-c888-44e4-9095-20817daaf7d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	2
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	2
ARGAN OIL	INACTIVE INGREDIENT	4V59G5UW9X	2
BETULA PUBESCENS BARK	INACTIVE INGREDIENT	3R504894L9	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	2
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	2
LEPTOSPERMUM PETERSONII LEAF OIL	INACTIVE INGREDIENT	N37UWG52T3	2
PORPHYRIDIUM PURPUREUM	INACTIVE INGREDIENT	K2P8K2558N	2
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	2
RUTIN	INACTIVE INGREDIENT	5G06TVY3R7	2
SAMBUCUS NIGRA FLOWER	INACTIVE INGREDIENT	07V4DX094T	2
SCROPHULARIA NODOSA	INACTIVE INGREDIENT	7H443NUB2T	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Wound Healing
Calendula Officinalis
CALENDULA OFFICINALIS FLOWERING TOP
ARGAN OIL
BETULA PUBESCENS BARK
CETEARYL OLIVATE
CHLORPHENESIN
CITRIC ACID MONOHYDRATE
CARNAUBA WAX
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
ISOPROPYL PALMITATE
LEPTOSPERMUM PETERSONII LEAF OIL
PORPHYRIDIUM PURPUREUM
POTASSIUM CITRATE
RUTIN
SAMBUCUS NIGRA FLOWER
SCROPHULARIA NODOSA
SODIUM HYDROXIDE
SORBITAN OLIVATE
WATER
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76029-003	76029-003-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALENDULA OFFICINALIS FLOWERING TOP	18E7415PXQ	ACTIB
ARGAN OIL	4V59G5UW9X	IACT
BETULA PUBESCENS BARK	3R504894L9	IACT
CETEARYL OLIVATE	58B69Q84JO	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LEPTOSPERMUM PETERSONII LEAF OIL	N37UWG52T3	IACT
PORPHYRIDIUM PURPUREUM	K2P8K2558N	IACT
POTASSIUM CITRATE	EE90ONI6FF	IACT
RUTIN	5G06TVY3R7	IACT
SAMBUCUS NIGRA FLOWER	07V4DX094T	IACT
SCROPHULARIA NODOSA	7H443NUB2T	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN OLIVATE	MDL271E3GR	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	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 7 · 395 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	78.36 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	DISC / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	AEROSOL, FOAM / TOPICAL		12 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE / ORAL	60 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPRAY / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 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
6b19cb05-d693-4975-abe9-25409fe02c9f			b4be80a4-c888-44e4-9095-20817daaf7d8	2011-03-30	Warnings	Exact identifier spl id: 6b19cb05-d693-4975-abe9-25409fe02c9f spl set id: b4be80a4-c888-44e4-9095-20817daaf7d8

Reported adverse events (FAERS/openFDA)#

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