DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (0.7595 g) Lanolin (0.155 g)

Inactive Ingredients

.alpha.-tocopherol Acetate Cetyl Esters Wax Ethyl Methylphenylglycidate Benzyl Cinnamate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-02-01

Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness

Dosage and Administration

Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.

Description

Active Ingredients Amber Petroluatum 75.95%........... Lanolin 15.50%..............................

Section 42229-5

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50566-9

Stop use and ask a doctor if • condition worsens • symtoms last more than 7 day or clear up and occur again within a few days

Section 50567-7

When using this product • do not get into eyes

Section 50570-1

Do not use on • deep or puncture wounds • animal bites • serious burns

Section 51727-6

Other Ingredients:

Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)

Section 53413-1

For Questions call (800) 457-0990 Mon-Fri

Section 55105-1

Purpose

.......Protectant, Emollient

.......Protectant, Emollient

Section 55106-9

Active Ingredients

Amber Petroluatum 75.95%...........

Lanolin 15.50%..............................

Section 60561-8

Other Information: Store at 20° to 25°C (68° to 77°F)

———package Label.principal Disply Panel———

Warnings continued: Do not use on: • deep or puncture

wounds • animals bites • serious burns

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

Directions: Change wet and soiled diapers promptly.

Cleans diaper area and allow to dry. Apply a thin film of

ointment to entire diaper area with every diaper change.

Other Information: Store at 20° to 25°C (68° to 77°F)

Other Ingredients:

Tocopherol Acetate (Vitamin E), Cetyl Esters,

Ethyl Methylphenylglycidate, Benzyl Cinnamate

(extracts of balsam of peru)

For Questions call (800) 457-0990 Mon-Fri

Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

wwwGrandmaEls.com

Creates a

Breathable Barrier

Use with Every

Diaper Change

Soothes, Calms

+ Heals

NET WT 3.75 OZ.

GRANDMA EL'S

Diaper Rash Ointment

Made in the USA

Pediatrician Recommended

DOES NOT CONTAIN

PARABENS,

PHTHALATES OR SLS

DRUG FACTS:

Active Ingredients Purpose

Amber Petrolatum 75.95%..........Protectant, Emollient

Lanolin USP 15.50%...................Protectant, Emollient

Uses: Helps treat and prevent diaper rash

Protects and heals chafed and irritated skin
Provides barrier to seal out wetness

Warnings:

For external use only

When using this product • do not get into eyes

Stop use and ask a doctor if • condition worsens

• symptoms last more than 7 days or clear up and

occur again within a few days

2001-16

3 52248 00001 5

Structured Label Content

Indications and Usage (34067-9)

Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness

Dosage and Administration (34068-7)

Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50566-9 (50566-9)

Stop use and ask a doctor if • condition worsens • symtoms last more than 7 day or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product • do not get into eyes

Section 50570-1 (50570-1)

Do not use on • deep or puncture wounds • animal bites • serious burns

Section 51727-6 (51727-6)

Other Ingredients:

Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)

Section 53413-1 (53413-1)

For Questions call (800) 457-0990 Mon-Fri

Section 55105-1 (55105-1)

Purpose

.......Protectant, Emollient

.......Protectant, Emollient

Section 55106-9 (55106-9)

Active Ingredients

Amber Petroluatum 75.95%...........

Lanolin 15.50%..............................

Section 60561-8 (60561-8)

Other Information: Store at 20° to 25°C (68° to 77°F)

———package Label.principal Disply Panel——— (———PACKAGE LABEL.PRINCIPAL DISPLY PANEL———)

Warnings continued: Do not use on: • deep or puncture

wounds • animals bites • serious burns

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

Directions: Change wet and soiled diapers promptly.

Cleans diaper area and allow to dry. Apply a thin film of

ointment to entire diaper area with every diaper change.

Other Information: Store at 20° to 25°C (68° to 77°F)

Other Ingredients:

Tocopherol Acetate (Vitamin E), Cetyl Esters,

Ethyl Methylphenylglycidate, Benzyl Cinnamate

(extracts of balsam of peru)

For Questions call (800) 457-0990 Mon-Fri

Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

wwwGrandmaEls.com

Creates a

Breathable Barrier

Use with Every

Diaper Change

Soothes, Calms

+ Heals

NET WT 3.75 OZ.

GRANDMA EL'S

Diaper Rash Ointment

Made in the USA

Pediatrician Recommended

DOES NOT CONTAIN

PARABENS,

PHTHALATES OR SLS

DRUG FACTS:

Active Ingredients Purpose

Amber Petrolatum 75.95%..........Protectant, Emollient

Lanolin USP 15.50%...................Protectant, Emollient

Uses: Helps treat and prevent diaper rash

Protects and heals chafed and irritated skin
Provides barrier to seal out wetness

Warnings:

For external use only

When using this product • do not get into eyes

Stop use and ask a doctor if • condition worsens

• symptoms last more than 7 days or clear up and

occur again within a few days

2001-16

3 52248 00001 5

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "0.7595", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "ACTIB", "strengthNumerator": "0.155", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL METHYLPHENYLGLYCIDATE", "unii": "UD51D5KR4A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL CINNAMATE", "unii": "V67O3RO97U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness", "34068-7": "Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.", "34071-1": "Warnings: For external use only", "42229-5": "Mfd. by ABBE Laboratories, Inc. Farmingdale, NY www.GrandmaEls.com", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center", "50566-9": "Stop use and ask a doctor if • condition worsens • symtoms last more than 7 day or clear up and occur again within a few days", "50567-7": "When using this product • do not get into eyes", "50570-1": "Do not use on • deep or puncture wounds • animal bites • serious burns", "51727-6": "Other Ingredients: Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)", "53413-1": "For Questions call (800) 457-0990 Mon-Fri", "55105-1": "Purpose .......Protectant, Emollient .......Protectant, Emollient", "55106-9": "Active Ingredients Amber Petroluatum 75.95%........... Lanolin 15.50%..............................", "60561-8": "Other Information: Store at 20° to 25°C (68° to 77°F)", "———PACKAGE LABEL.PRINCIPAL DISPLY PANEL———": "Warnings continued: Do not use on: • deep or puncture wounds • animals bites • serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Directions: Change wet and soiled diapers promptly. Cleans diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change. Other Information: Store at 20° to 25°C (68° to 77°F) Other Ingredients: Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzyl Cinnamate (extracts of balsam of peru) For Questions call (800) 457-0990 Mon-Fri Mfd. by ABBE Laboratories, Inc. Farmingdale, NY wwwGrandmaEls.com Creates a Breathable Barrier Use with Every Diaper Change Soothes, Calms + Heals NET WT 3.75 OZ. GRANDMA EL'S Diaper Rash Ointment Made in the USA Pediatrician Recommended DOES NOT CONTAIN PARABENS, PHTHALATES OR SLS DRUG FACTS: Active Ingredients Purpose Amber Petrolatum 75.95%..........Protectant, Emollient Lanolin USP 15.50%...................Protectant, Emollient Uses: Helps treat and prevent diaper rash Protects and heals chafed and irritated skin Provides barrier to seal out wetness Warnings: For external use only When using this product • do not get into eyes Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days 2001-16 3 52248 00001 5"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information