DIABETIC BRUISE DEFENSE by Genuine Virgin Aloe Corporation

DIABETIC BRUISE DEFENSE by

Drug Labeling and Warnings

DIABETIC BRUISE 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 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

DIABETIC BRUISE DEFENSE 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-301
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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-301-54	1 in 1 BOX	01/02/2014	08/01/2019
1	NDC: 10738-301-14	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	08/01/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-301)

Revised: 1/2020

Document Id: 09c43258-b216-45bf-a607-4cf7f6369520

34390-5

Set id: f05826b2-d74d-44c6-bbfe-095216237779

Version: 5

Effective Time: 20200113