SPL v2
SPL
SPL Set ID 35aca592-bfd0-652f-e063-6394a90ac53e
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.9985 g)
Inactive Ingredients
Cholecalciferol Vitamin A Palmitate .alpha.-tocopherol Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-03

Description

Petrolatum 99.85%


Medication Information

Warnings and Precautions

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • conditions worsens
  • symptoms last moe than 7 days or clear ip and occur again within a few days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. if sallowed , get medical help or contact a Poison Control center right away.

Indications and Usage

Uses

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve chapped, chafed, or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Dosage and Administration

apply as neede

Description

Petrolatum 99.85%

Section 44425-7

Other information

store between 20°C to 25°C (68°F to 77°F)

avoid direct sunlight

Section 50565-1

Keep out of reach of children.

Section 50566-9

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
Section 50567-7

When using this product

  • do not get into eyes
Section 50569-3

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
Section 50570-1

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51727-6

Inactive ingredients

medium chain triglyceride oil, vitamin A palmitate, vitamin D3, vitamin E (alpha-tocopherol)

Section 51945-4

Gentell We make it better

GEN-23450

A&D+E ointment

Skin Protectant

13 oz. (369 g)

Gentell 104 Shorting Rd, Toronto , ON, Canada M1S 3S4 www.gentell.com

Section 53413-1

Questions?



Call 1-800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

Section 55105-1

Skin Protectant

Section 55106-9

Petrolatum 99.85%

Section 59845-8

Directions

  • apply as needed
Section 60561-8

For external use only

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


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve chapped, chafed, or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Dosage and Administration (34068-7)

apply as neede

Warnings and Precautions (34071-1)

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • conditions worsens
  • symptoms last moe than 7 days or clear ip and occur again within a few days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. if sallowed , get medical help or contact a Poison Control center right away.

Section 44425-7 (44425-7)

Other information

store between 20°C to 25°C (68°F to 77°F)

avoid direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51727-6 (51727-6)

Inactive ingredients

medium chain triglyceride oil, vitamin A palmitate, vitamin D3, vitamin E (alpha-tocopherol)

Section 51945-4 (51945-4)

Gentell We make it better

GEN-23450

A&D+E ointment

Skin Protectant

13 oz. (369 g)

Gentell 104 Shorting Rd, Toronto , ON, Canada M1S 3S4 www.gentell.com

Section 53413-1 (53413-1)

Questions?



Call 1-800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Petrolatum 99.85%

Section 59845-8 (59845-8)

Directions

  • apply as needed
Section 60561-8 (60561-8)

For external use only

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)