TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER- allantoin, dimethicone cream

TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER by

Drug Labeling and Warnings

TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER 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 ingredients

Allantoin 1.5%

Dimethicone 2%

Purpose

Skin Protectant

Uses helps treat and prevent diaper rash. Protects chafed skin/minor skin irritation due to/associated with diaper rash helps protect from/seal out wetness temporarily protect and helps relieve chafed, chapped, or cracked skin

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 gently clean the irritated area before use. Then apply a generous layer of cream. It can be left on thick or rubbed into skin. Use as many times a day as necessary until healed. For continuous protection and healthy skin, use daily or as needed.

STORAGE AND HANDLING

Other information store at room temperature use on infants, children or adults

INACTIVE INGREDIENT

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, aloe barbadensis leaf juice*, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, panthenol (pro-vitamin B-5), tocopheryl acetate (vitamin E), glyceryl stearate, silica, sodium hyaluronate, sodium phytate, potassium cetyl phosphate, xanthan gum, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.*Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Helps treat and prevent diaper rash
Temporarily protects and helps relieve chafed, chapped, or cracked skin

AP4® BOTANICAL

ALOE VERA COMPLEX

Allantoin & Dimenthicone

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

Packaging

Packaging

Packaging

INGREDIENTS AND APPEARANCE

TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SAFFLOWER OIL (UNII: 65UEH262IS)
OATMEAL (UNII: 8PI54V663Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ZINC PIDOLATE (UNII: C32PQ86DH4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHYTATE SODIUM (UNII: 88496G1ERL)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
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: 10738-061-45	113 g in 1 TUBE; Type 0: Not a Combination Product	08/30/2019
2	NDC: 10738-061-50	1 in 1 CARTON	08/30/2019
2	NDC: 10738-061-55	14 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	08/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-061)