DIABETIC BRUISE DEFENSE- allantoin 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 .5%

PURPOSE

SKIN PROTECTANT

USES

  • HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED, CRACKED, OR WIND-BURNED SKIN AND LIPS
  • FOR THE TEMPORARY PROTECTION OF MINOR CUTS, SCAPES, BURNS, AND SUNBURN

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 to bruised or injured skin as soon as possible. repeat several times a day.

Inactive ingredients: alkyl benzoate, aloe barbadensis (aloe vera) leaf extract, AP4® genuine virgin aloe complex, arnica (montana flower) extract, beeswax, cetearyl alcohol, cyclomethicone, disodium EDTA, glyceryl stearate, methylsulfonylmethane (MSM), petrolatum, phenoxyethanol, tocopheryl acetate (vitamin E)

QUESTIONS?

CALL 800-279-7282

OR VISIT WWW.TRIDERMA.COM

Packaging

untitled

DIABETIC BRUISE DEFENSE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10738-301-541 in 1 BOX01/02/201408/01/2019
1NDC:10738-301-14119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/201408/01/2019
Labeler - Genuine Virgin Aloe Corporation (961374147)
Establishment
NameAddressID/FEIBusiness Operations
Genuine Virgin Aloe Corporation961374147manufacture(10738-301)

Revised: 1/2020
Document Id: 09c43258-b216-45bf-a607-4cf7f6369520
Set id: f05826b2-d74d-44c6-bbfe-095216237779
Version: 5
Effective Time: 20200113
 
Genuine Virgin Aloe Corporation