TRIDERMA ULCER DEFENSE HEALING- calendula officinalis cream

TRIDERMA ULCER DEFENSE HEALING by

Drug Labeling and Warnings

TRIDERMA ULCER DEFENSE HEALING by is a Homeopathic medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredient

Calendula Officinalis 1X HPUS 1.5%

Purpose 

Speed healing, Minimizes recurrence, healing agent.

HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE

Uses speed healing of wounds, sores, acne and lip sores helps promote healing of cuts, scrapes, chafing, minor burns and sunburn

WARNINGS

Warnings For external use only.

Avoid contact with eyes. Intended for adults only. Do not use if you are allergic to Calendula Officinalis or to this product's inactive ingredients.

Stop use and ask a doctor before use in case of deep puncture wounds, animal bites or serious burns and if condition persists for more than 4 days or worsens. 

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

DOSAGE & ADMINISTRATION

Directions read all package directions and warnings before use. When using this product use only as directed. Apply a thin layer to affected area and massage gently as soon as possible after minor injury. Apply 3X a day or as needed. Sensitivity Test for a New User. Apply sparingly to one or two small affected areas during the first 7 days. if no discomfort occurs, follow the direction stated above.

STORAGE AND HANDLING

Other information do not use if glued carton end flaps are open or if the tube seal is broken.  store at room temperature.

INACTIVE INGREDIENT

Inactive ingredients: water, cetearyl alcohol, isopropyl palmitate, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, avena sativa (oat) kernel flour, aloe barbadensis leaf juice†, butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), cetyl alcohol, sodium PCA, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.

†Certified Organic Ingredient — Mayacert Certifier 

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

Speed healing of wounds & sores

Helps promote healing of cuts, scrapes & chafing 

DIABETICS

AP4® Botanical

ALOE VERA COMPLEX

Calendula

Homeopathic Medicine

Maximum Strength

Healing Botanicals

Ulcer Defense™ Healing Cream is the perfect multi-purpose skin healer to help keep skin healthy and protected.

It provides soothing relief and helps speed healing for minor to severe, hard-to-heal™ skin irritations.

Formulated with our AP4® Organic Aloe* Complex, vitamins, minerals and essential healing botanicals, this powerful cream delivers fast results without harmful side effects.

www.triderma.com 

MADE IN THE USA 

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 

Dermatologist Tested

Speeds Healing For:

Minor Burns & Sunburn

Non-Greasy No Cortisone Or Parabens

No Added Fragrance

- Uses have not been evaluated by Food and Drug Administration.

- X is homeopathic dilutions.

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE.®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

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INGREDIENTS AND APPEARANCE

TRIDERMA ULCER DEFENSE HEALING 
calendula officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-057
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	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)
OATMEAL (UNII: 8PI54V663Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-057-50	1 in 1 CARTON	08/30/2019
1	NDC: 10738-057-55	14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10738-057-40	1 in 1 CARTON	08/30/2019
2	NDC: 10738-057-45	119 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10738-057-20	1 in 1 CARTON	08/30/2019
3	NDC: 10738-057-25	62 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-057)