WOUND HEALING- calendula officinalis cream

Wound Healing by

Drug Labeling and Warnings

Wound Healing by is a Homeopathic medication manufactured, distributed, or labeled by Active Release Techniques, Leo Desilets maitre herboriste Inc/Facotek Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Calendula (Calendula Officinalis)

PURPOSE

Antiseptic

INDICATIONS & USAGE

Topical relief for:

• wound healing
• cuts, scrapes and abrasions
• minor burns, sunburns

as per Homeopathic Materia Medica

WARNINGS

for external use only

DO NOT USE

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
  

ASK DOCTOR

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

STOP USE

Stop use and ask a doctor:

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

• Topical Cream for Wound Healing
• Natural Active Ingredient
• Non-Greasy

INGREDIENTS AND APPEARANCE

WOUND HEALING  
calendula officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76029-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_C]  in 35 g

Inactive Ingredients
Ingredient Name	Strength
ARGAN OIL (UNII: 4V59G5UW9X)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
RUTIN (UNII: 5G06TVY3R7)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
SCROPHULARIA NODOSA (UNII: 7H443NUB2T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76029-003-35	35 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/20/2011

Labeler - Active Release Techniques (174462593)

Registrant - Active Release Techniques (174462593)

Establishment
Name	Address	ID/FEI	Business Operations
Leo Desilets maitre herboriste Inc/Facotek Packaging		245423439	manufacture