DIABETIC FOOT DEFENSE by Genuine Virgin Aloe Corporation

DIABETIC FOOT DEFENSE by

Drug Labeling and Warnings

DIABETIC FOOT DEFENSE by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 FOOT DEFENSE 
allantoin and dimethicone cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/02/2014	09/13/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Registrant - Genuine Virgin Aloe Corporation (961374147)

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

Revised: 11/2019

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

34390-5

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

Version: 11

Effective Time: 20191118

 

Genuine Virgin Aloe Corporation