gnp zinc oxide ointment 2 oz. 43375 zdp

gnp zinc oxide ointment 2 oz. 43375 zdp
SPL v5
SPL
SPL Set ID c28e63f1-34be-9206-e053-2995a90accf6
Route
topical
Published
Effective Date 2021-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (0.2 g)
Inactive Ingredients
aloe vera leaf paraffin .alpha.-tocopherol acetate light mineral oil petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-05-17

Description

Active ingredient Purpose Zinc oxide 20%...............................................Skin protectant


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient Purpose

Zinc oxide 20%...............................................Skin protectant

Indications and Usage

Directions

  • for diaper rash:
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, sumac, chafed, chapped, cracked or windburned skin and lips:
  • apply liberally as often as needed
Dosage and Administration

Distributed by:

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Made in China

Description

Active ingredient Purpose Zinc oxide 20%...............................................Skin protectant

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
  • may stain clothing
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 51727-6

Inactive ingredients .alpha.-tocopherol acetate, aloe vera leaf, light mineral oil, praffin, petrolatum

Section 51945-4

Section 55105-1

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • protects and dries the oozing and weeping of poison ivy, oak and sumac
  • helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and lips

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient Purpose

Zinc oxide 20%...............................................Skin protectant

Indications and Usage (34067-9)

Directions

  • for diaper rash:
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, sumac, chafed, chapped, cracked or windburned skin and lips:
  • apply liberally as often as needed
Dosage and Administration (34068-7)

Distributed by:

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19087

Made in China

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
  • may stain clothing
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 51727-6 (51727-6)

Inactive ingredients .alpha.-tocopherol acetate, aloe vera leaf, light mineral oil, praffin, petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • protects and dries the oozing and weeping of poison ivy, oak and sumac
  • helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and lips

Advanced Ingredient Data


Raw Label Data

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