TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER- allantoin, dimethicone cream 
Genuine Virgin Aloe Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TRIDERMA Protect & Heal Non-Greasy Barrier

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 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.

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.

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

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

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 

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TRIDERMA PROTECT AND HEAL NON- GREASY BARRIER 
allantoin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10738-061-45113 g in 1 TUBE; Type 0: Not a Combination Product08/30/2019
2NDC:10738-061-501 in 1 CARTON08/30/2019
2NDC:10738-061-5514 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2019
Labeler - Genuine Virgin Aloe Corporation (961374147)
Establishment
NameAddressID/FEIBusiness Operations
Genuine Virgin Aloe Corporation961374147manufacture(10738-061)

Revised: 2/2023
Document Id: f3bd7bf8-e277-6121-e053-2995a90aa3ef
Set id: 3209f075-90bf-4141-b5f3-8175c1ee6ba0
Version: 3
Effective Time: 20230202
 
Genuine Virgin Aloe Corporation