TRIDERMA INTENSE FAST HEALING MULTI-PURPOSE CREAM- calendula officinalis cream

TRIDERMA Intense Fast Healing Multi-Purpose Cream by

Drug Labeling and Warnings

TRIDERMA Intense Fast Healing Multi-Purpose Cream 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 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

Helps promote healing of cuts, scrapes, chafing, minor burns & sunburn

Speed healing of wounds, sores, acne & lip sores

AP 4® BOTANICAL

ALOE VERA COMPLEX

Homeopathic Medicine

Maximum Strength Healing Botanicals

This is the perfect ‘must-have’ all-purpose healing cream for every medicine cabinet.

It provides soothing relief for dry, cracked skin, minor cuts, scrapes, burns, hard-tohealTM skin irritations and much more.

Infused with our AP4® Organic Aloe* Complex, vitamins, minerals and essential botanicals, it delivers fast results without harmful side effects.

EXPERTS IN SKIN HEALING SINCE 1992

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

It all began after one women 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.

Non-Greasy No Cortisone Or Parabens

 No Added Fragrance

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

- X is homeopathic dilutions.

MADE IN THE USA

www.triderma.com

Dist. by: Genuine Virgin Aloe Corp, Corona, CA 92879 © 2019

Item 60425 0919 

Packaging

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA INTENSE FAST HEALING MULTI-PURPOSE CREAM 
calendula officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	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)
WHITE WAX (UNII: 7G1J5DA97F)
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: 10738-060-50	1 in 1 CARTON	12/30/2019
1	NDC: 10738-060-55	14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10738-060-20	1 in 1 CARTON	12/30/2019
2	NDC: 10738-060-25	62 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10738-060-40	1 in 1 CARTON	12/30/2019
3	NDC: 10738-060-45	119 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		12/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-060)