TRIDERMA PRESSURE SORE RELIEF- calendula officinalis cream

TRIDERMA PRESSURE SORE RELIEF by

Drug Labeling and Warnings

TRIDERMA PRESSURE SORE RELIEF 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 3 days. if no discomfort occurs, follow the direction stated above. 

OTHER SAFETY INFORMATION

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, cuts, scrapes, chafing & minor burns
AP4 BOTANICAL
ALOE VERA COMPLEX
Calendula
Homeopathic Medicine

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

-X is homeopathic dilutions. 

www.triderma.com

Dist. by: Genuine Virgin Aloe corp., Corona, CA 92879 Made in USA 

EXPERTS IN SKIN HEALING SINCE 1992

Pressure Sore Relief is specifically formulated to help protect and promote relief for red, irritated, chapped or cracked skin. Use daily to help protect against skin breakdown.

This non-greasy formula has become a customer favorite for those that use a wheelchair, have prosthetic limbs, or are bed-ridden to help keep skin healthy.

Packaging

Packaging

Packaging

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA PRESSURE SORE RELIEF 
calendula officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-210
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: 10738-210-50	1 in 1 CARTON	08/30/2019
1	NDC: 10738-210-55	14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10738-210-41	113 g in 1 JAR; Type 0: Not a Combination Product	08/30/2019
3	NDC: 10738-210-45	113 g in 1 TUBE; Type 0: Not a Combination Product	08/30/2019

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(10738-210)