Sbs 40

Sbs 40
SPL v10
SPL
SPL Set ID 08e8ecd8-1ea0-4d84-9790-55d73bf0eb07
Route
TOPICAL
Published
Effective Date 2017-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (5 mg)
Inactive Ingredients
Water Carbomer 934 Cetyl Esters Wax Petrolatum Isopropyl Palmitate Lanolin Triethanolamine Benzoate Diazolidinyl Urea Phenoxyethanol Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2013-01-01 Until 2017-03-01

Description

Allantoin, 0.5%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Allantoin, 0.5%

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Section 50565-1

Keep out of reach of children

Section 51945-4

deb

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 Liter

85 Fluid Ounces

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

40108

Rev. 01-13

Warnings

For external use only

Directions

apply to clean, dry hands as needed

rub in well

Do Not Use On

deep or puncture wounds

animal bites

serious burns

Active Ingredient

Allantoin, 0.5%

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance

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


Structured Label Content

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

deb

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 Liter

85 Fluid Ounces

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

40108

Rev. 01-13

Purpose

Skin Protectant

Warnings

For external use only

Directions

apply to clean, dry hands as needed

rub in well

Do Not Use On (Do not use on)

deep or puncture wounds

animal bites

serious burns

Active Ingredient (Active ingredient)

Allantoin, 0.5%

Inactive Ingredients (Inactive ingredients)

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance

When Using This Product (When using this product)

avoid contact with eyes.

In case of eye contact, flush with water.

Stop Use and Ask A Doctor If (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)