Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 52b86b15-5df4-4042-ac2b-b96fbd3db0a7
Route
TOPICAL
Published
Effective Date 2010-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 mL)
Inactive Ingredients
Cetyl Esters Wax Petrolatum Isopropyl Palmitate Carbomer 934 Trolamine Chloroxylenol Methylparaben Lanolin Propylparaben Stearyl Alcohol Polyoxyl 20 Cetostearyl Ether Methylchloroisothiazolinone Methylisothiazolinone Magnesium Nitrate Magnesium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-01

Description

Active Ingredient Allantoin, 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only



Indications and Usage

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Dosage and Administration

Directions

Apply SBS-40 as needed

Description

Active Ingredient Allantoin, 0.5%

Section 50565-1

Keep out of the reach of children

Section 50566-9

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

Section 50567-7

When using this product do not get in eyes

Section 50570-1

Enter section text here

Section 51727-6

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.

Section 51945-4

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

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredient

Allantoin, 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Dosage and Administration (34068-7)

Directions

Apply SBS-40 as needed

Warnings and Precautions (34071-1)

Warnings

For external use only



Section 50565-1 (50565-1)

Keep out of the reach of children

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not get in eyes

Section 50570-1 (50570-1)

Enter section text here

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active Ingredient

Allantoin, 0.5%


Advanced Ingredient Data


Raw Label Data

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