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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10738-304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.1 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10738-304-54	1 in 1 BOX	01/02/2014	06/07/2018
1	NDC:10738-304-14	119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/02/2014	06/07/2018

Labeler - Genuine Virgin Aloe Corporation (743159706)

Registrant - Genuine Virgin Aloe Corporation (743159706)

Revised: 5/2019

Document Id: 793618e0-3ede-4a56-bf06-82369d694d71

Set id: d944b8aa-1bbb-4b68-819c-394ec5a295ac

Version: 7

Effective Time: 20190528

Genuine Virgin Aloe Corporation