SPL v1
SPL
SPL Set ID 37eff762-1ea9-ec66-e063-6394a90a3d10
Route
TOPICAL
Published
Effective Date 2014-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.2 g)
Inactive Ingredients
Petrolatum Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-03

Description

Zinc Oxide 20%


Medication Information

Warnings and Precautions

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

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

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

Indications and Usage

Uses

dries the oozing and weeping of:

■ poison ivy ■ poison oak ■ poison sumac

Dosage and Administration

Directions

  • apply as needed
Description

Zinc Oxide 20%

Section 44425-7

Other Information

store between 15ºC to 30ºC (59ºF to 86ºF)

avoid excessive heat

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 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 puncture wounds
  • animal bites
  • serious burns
Section 51727-6

light mineral oil, petrolatum

Section 51945-4

Section 53413-1

Questions?

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

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 20%


Structured Label Content

Indications and Usage (34067-9)

Uses

dries the oozing and weeping of:

■ poison ivy ■ poison oak ■ poison sumac

Dosage and Administration (34068-7)

Directions

  • apply as needed
Warnings and Precautions (34071-1)

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

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

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

Section 44425-7 (44425-7)

Other Information

store between 15ºC to 30ºC (59ºF to 86ºF)

avoid excessive heat

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

light mineral oil, petrolatum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call 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)

Zinc Oxide 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)