DIABETIC FOOT 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 1.5%

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 aloe barbadensis (aloe vera) leaf extract, AP4® genuine virgin aloe complex, avena sativa (oat) kernel extract, beeswax,
butyrospermum parkii (shea butter), cetearyl alcohol (plant derived), cetyl alcohol (plant derived), ethylhexylglycerin (plant derived), gluconolactone (corn derived), lactic acid, panthenol (pro-vitamin B5), phenoxyethanol, polysorbate-60 (plant derived), sodium benzoate (plant derived), sodium hyaluronate, sodium lactate, urea, squalane, tetrasodium EDTA, tocopheryl acetate (vitamin E), zinc PCA

QUESTIONS?

CALL 800-279-7282

OR VISIT WWW.TRIDERMA.COM

Diabetic_GVA1207_42oz_Cartons_Foot

DIABETIC FOOT DEFENSE
allantoin and dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10738-303
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OATMEAL (UNII: 8PI54V663Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
UREA (UNII: 8W8T17847W)
SQUALANE (UNII: GW89575KF9)
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC PIDOLATE (UNII: C32PQ86DH4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10738-303-54	1 in 1 BOX	01/02/2014	09/13/2019
1	NDC:10738-303-14	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	09/13/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Registrant - Genuine Virgin Aloe Corporation (961374147)

Name	Address	ID/FEI	Business Operations
Establishment
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-303)

Revised: 11/2019

Document Id: 622f8f7f-e101-46fb-86d7-12a49d2fc866

Set id: 56204b05-8564-477d-9f0c-74b019c8e427

Version: 11

Effective Time: 20191118

Genuine Virgin Aloe Corporation