SBS 40- allantoin lotion

SBS 40 by

Drug Labeling and Warnings

SBS 40 by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Allantoin, 0.5%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For external use only

When using this product do not get in eyes

Stop use and ask a doctor if

conditions worsen

symptoms last more than 7 days

or clear up and occur again within a few days

Enter section text here

Keep out of the reach of children

DOSAGE & ADMINISTRATION

Directions

Apply SBS-40 as needed

INACTIVE INGREDIENT

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Stearyl Alcohol, Carbomer, Triethanolamine, Ceteareth-20, Chloroxylenol, Methylparaben, Lanolin, Propylparaben, Fragrance, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

PRINCIPAL DISPLAY PANEL

deb

SBS 40

Medicated Skin Cream

Skin Protectant

1-Protect

2-Cleanse

3-Restore

85 fl. oz. 2.5 liters

Made in U.S.A.

40108-05-026

Contains a blend of emollients including lanolin to keep skin soft and supple.

Recommended for professionals and individuals who have chapped or cracker hands.

Soothes and protects dry or chapped skin

INGREDIENTS AND APPEARANCE

SBS 40 
allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	0.5 mL  in 100  mL

Inactive Ingredients
Ingredient Name	Strength
Cetyl Esters Wax (UNII: D072FFP9GU)
Petrolatum (UNII: 4T6H12BN9U)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Carbomer 934 (UNII: Z135WT9208)
Trolamine (UNII: 9O3K93S3TK)
Chloroxylenol (UNII: 0F32U78V2Q)
Methylparaben (UNII: A2I8C7HI9T)
Lanolin (UNII: 7EV65EAW6H)
Propylparaben (UNII: Z8IX2SC1OH)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-040-08	2500 mL in 1 BOTTLE, PLASTIC
2	NDC: 11084-040-35	148 mL in 1 TUBE
3	NDC: 11084-040-39	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2010

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture