Drug Labeling and Warnings

Drug Details [pdf]

DIABETIC ULCER DEFENSE- allantoin and 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.

----------

ACTIVE INGREDIENT

ALLANTOIN 1.1%

DIMETHICONE 1.5%

PURPOSE:

SKIN PROTECTANT

Uses

  • temporarily protects minor
  • cuts
  • scrapes
  • burns
  • helps prevent and temporarily protect 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

  • avoid contact with 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:

  • APPLY GENEROUSLY 1 TO 3 TIMES DAILY, OR AS DIRECTED BY A DOCTOR

Inactive ingredients

algae (seaweed) extract, aloe barbadensis (aloe vera) leaf extract, AP4® genuine virgin aloe complex, artemisia vulgaris
(mugwort/armoise) oil, avena sativa (oat) kernel extract, beeswax, carthamus tinctorius (safflower) seed oil, cetearyl alcohol (plant derived),
cetyl alcohol (plant derived), disodium EDTA, ethylhexylglycerin (plant derived), methylisothiazolinone, panthenol (pro-vitamin B5), phenoxyethanol, polysorbate-60 (plant derived), prolatum oil, retinyl palmitate (vitamin A), sodium hyaluronate, sodium PCA, sorbic acid,
squalane, tocopheryl acetate (vitamin E), zinc PCA

QUESTIONS?

CALL 800-279-7282

OR VISIT WWW.TRIDERMA.COM

Diabetic_GVA1207_42oz_Cartons_Ulcer

DIABETIC ULCER DEFENSE 
allantoin and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10738-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.1 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)  
OATMEAL (UNII: 8PI54V663Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PETROLATUM (UNII: 4T6H12BN9U)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PIDOLATE (UNII: 1V74VH163T)  
SORBIC ACID (UNII: X045WJ989B)  
SQUALANE (UNII: GW89575KF9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10738-304-541 in 1 BOX01/02/201406/07/2018
1NDC: 10738-304-14119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/201406/07/2018
Labeler - Genuine Virgin Aloe Corporation (743159706)
Registrant - Genuine Virgin Aloe Corporation (743159706)

Revised: 5/2019