DIABETIC DRY SKIN 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

helps prevent and temporarily protect chafed, chapped, cracked skin
helps protect from the drying effects of wind and cold weather

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, avocado oil, beeswax, cetearyl alcohol,
cetyl alcohol, disodium EDTA, glycerin, glycyrrhiza glabra (licorice) extract, panthenol (pro vitamin B5), petrolatum, phenoxyethanol, polysorbate 60, retinyl palmitate (vitamin A), squalane, sodium PCA, tocopheryl acetate (vitamin E), urea, zinc PCA

QUESTIONS?

CALL 800-279-7282

OR VISIT WWW.TRIDERMA.COM

Diabetic_GVA1207_42oz_Cartons_DrySkin

DIABETIC DRY SKIN DEFENSE
allantoin and dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10738-302
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVOCADO OIL (UNII: 6VNO72PFC1)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SQUALANE (UNII: GW89575KF9)
SODIUM PIDOLATE (UNII: 1V74VH163T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
ZINC PIDOLATE (UNII: C32PQ86DH4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10738-302-54	1 in 1 BOX	01/02/2014	09/13/2019
1	NDC:10738-302-14	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(10738-302)

Revised: 11/2019

Document Id: edb94d31-7638-42ea-b98a-ba4891fd5f34

Set id: f2e7232f-e682-4648-816a-771bc1d18103

Version: 8

Effective Time: 20191114

Genuine Virgin Aloe Corporation