Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9df87983-deb7-409d-8bea-234160010b0a
Route
TOPICAL
Published
Effective Date 2010-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 mL)
Inactive Ingredients
Water Cetyl Esters Wax Petrolatum Isopropyl Palmitate Chloroxylenol Carbomer 934 Hydroxyethyl Cellulose (4000 Cps At 1%) Methylparaben Ethanolamine Propylparaben Stearyl Alcohol Polyoxyl 20 Cetostearyl Ether

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

Helps relieve chapped or cracked skin

Helps prevent and protect from the drying effects of wind and cold weather

Dosage and Administration

Directions

Apply to clean hands

Rub in well

Re-apply after handwashing or as needed

Description

Active Ingredient Allantoin, 0.5%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with the eyes.

In case of eye contact, flush with water.

Section 51727-6

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isoproply Palmitate, Stearyl Alcohol, Ceteareth-20, Chloroxylenol, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Methylparaben, Ethanolamine, Propylparaben, Fragrance.

Section 51945-4

Cool Melon

Medicated Skin Cream

Non-Greasy, Silicone-Free

Conditions and relieves dry, hard-working hands

deb

Proudly made in the USA by Deb

40227-00-100

1 Liter - 33.8 Fluid Ounces 

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredient

Allantoin, 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps relieve chapped or cracked skin

Helps prevent and protect from the drying effects of wind and cold weather

Dosage and Administration (34068-7)

Directions

Apply to clean hands

Rub in well

Re-apply after handwashing or as needed

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

In case of eye contact, flush with water.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isoproply Palmitate, Stearyl Alcohol, Ceteareth-20, Chloroxylenol, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Methylparaben, Ethanolamine, Propylparaben, Fragrance.

Section 51945-4 (51945-4)

Cool Melon

Medicated Skin Cream

Non-Greasy, Silicone-Free

Conditions and relieves dry, hard-working hands

deb

Proudly made in the USA by Deb

40227-00-100

1 Liter - 33.8 Fluid Ounces 

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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