DIABETIC FOOT DEFENSE- allantoin and dimethicone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Genuine Virgin Aloe Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PURPOSE: SKIN PROTECTANT Uses - temporarily protects minor - cuts - scrapes - burns - helps prevent and temporarily protect chafed, chapped or cracked skin DO NOT USE - ON DEEP PUNCTURE WOUNDS - ON INFECTIONS - ON LACERATIONS STOP USE AND ASK A DOCTOR IF - condition worsens or does not improve within 7 days
Authorization status:
OTC monograph final
Authorization number:
10738-303-14, 10738-303-54

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

QUESTIONS?

CALL 800-279-7282

OR VISIT WWW.TRIDERMA.COM

DIABETIC FOOT DEFENSE

allantoin and dimethicone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 738 -30 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Genuine Virgin Aloe Corporation

ALLANTO IN (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z)

ALLANTOIN

0 .5 g in 10 0 g

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

O ATMEAL (UNII: 8 PI54V6 6 3Y)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

SHEA BUTTER (UNII: K49 155WL9 Y)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

LACTIC ACID (UNII: 33X0 4XA5AT)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

SO DIUM LACTATE (UNII: TU7HW0 W0 QT)

UREA (UNII: 8 W8 T178 47W)

SQ UALANE (UNII: GW8 9 575KF9 )

EDETATE SO DIUM TETRAHYDRATE (UNII: L13NHD21X6 )

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

ZINC PIDO LATE (UNII: C32PQ8 6 DH4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 738 -30 3-54

1 in 1 BOX

0 1/0 2/20 14

1

NDC:10 738 -30 3-14

119 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 1/0 2/20 14

Labeler -

Genuine Virgin Aloe Corporation (743159706)

Registrant -

Genuine Virgin Aloe Corporation (743159706)

Revised: 5/2019

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