TRIDERMA ECZEMA FAST HEALING FACE AND BODY- colloidal oatmeal cream

TRIDERMA ECZEMA FAST HEALING FACE AND BODY by

Drug Labeling and Warnings

TRIDERMA ECZEMA FAST HEALING FACE AND BODY by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Colloidal oatmeal 1.5%

Purpose

Skin protectant

INDICATIONS & USAGE

Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

WARNINGS

Warnings For external use only.

Do not use on deep puncture wounds on infections on lacerations

When using this product do not get into eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

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

DOSAGE & ADMINISTRATION

Directions apply twice a day or as needed.

STORAGE AND HANDLING

Other Information store at room temperature.

INACTIVE INGREDIENT

Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, 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

Temporarily protects & helps relieve minor skin irritation due to eczema & rashes
Helps relieve itching

AP4 BOTANICAL

ALOE VERA COMPLEX

with Colloidal Oatmeal

Maximum Strength
Healing Botanicals

Eczema Fast Healing™ cream helps promote fast relief for itching and rashes due to Eczema related symptoms.
This rich cream contains essential healing botanicals, vitamins and AP4® Aloe Vera Complex. It provides long lasting moisture and helps
relieve itching without harmful drugs.

Non-Greasy
No Added Fragrance or Parabens

Dist. by: Genuine Virgin Aloe Corp.,

Corona, CA 92879

AP4® Aloe Vera Complex, a proprietary botanical blend

Colloidal Oatmeal, helps relieve skin irritations due to Eczema and rashes

Shea Butter, Arnica Montana Flower & Beeswax

Vitamins B and E

DERMATOLOGIST TESTED

Rooted from a medical heritage, TriDerma MD® was founded after one woman’s struggle to find safe and effective skin healing.
At TriDerma MD®, we strive to create the perfect healing formulations for specific skin irritations. Our products are made using only
the finest quality, most effective ingredients. We are passionate in our pursuit of fast healing, natural botanicals that do not cause
harmful side effects.

Quality you can feel,
results you can see.®

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA ECZEMA FAST HEALING FACE AND BODY 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
UREA (UNII: 8W8T17847W)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WHITE WAX (UNII: 7G1J5DA97F)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETYL ALCOHOL (UNII: 936JST6JCN)
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: 10738-054-50	1 in 1 CARTON	10/01/2019
1	NDC: 10738-054-55	14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10738-054-20	1 in 1 CARTON	10/01/2019
2	NDC: 10738-054-25	62 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10738-054-40	1 in 1 CARTON	10/01/2019
3	NDC: 10738-054-45	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
OTC monograph final	part347	10/01/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-054)