SBS 41 allantoin cream

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

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Active ingredient:
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)
Available from:
Deb USA, Inc.
INN (International Name):
ALLANTOIN
Composition:
ALLANTOIN 5 mg in 1 mL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

SBS 41- allantoin cream

Deb USA, Inc.

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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Drug Facts

Active ingredient

Allantoin, 0.5%

Purpos e

Skin protectant

Us es

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not use on

deep or puncture wounds

animal bites

serious burns

When using this product

avoid contact with eyes.

In case of eye contact, flush with water.

Stop use and ask a doctor if

irritation or sensitivity develops

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

Directions

apply to clean, dry hands as needed

rub in well

Inactive ingredients

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol,Diazolidinyl

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol,Diazolidinyl

Urea, Ceteareth-20, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Ethanolamine, Fragrance

SBS 40 Medicated Skin Cream

Silicone-free

Non-irritating

Non-greasy formulation

Helps heal dry hard-working hands

Industry's preferred brand for over 50 years

2.5 Liters

85 Fluid Ounces

40108

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

Rev. 01-13

SBS 41

allantoin cream

Product Information

Deb USA, Inc.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:110 8 4-140

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ALLANTOIN

5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CETYL ESTERS WAX (UNII: D0 72FFP9 GU)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

PEG-7 5 LANO LIN (UNII: 0 9 179 OX7TB)

HYDRO XYETHYL CELLULO SE ( 4 0 0 0 CPS AT 1%) (UNII: ZYD53NBL45)

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

ETHANO LAMINE (UNII: 5KV8 6 114PT)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:110 8 4-140 -27

10 0 0 mL in 1 BOTTLE

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 1/20 13

Labeler -

Deb USA, Inc. (607378015)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Deb USA, Inc.

6 0 7378 0 15

ma nufa c ture (110 8 4-140 )

Revised: 5/2013

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