SPL v7
SPL
SPL Set ID 9eb0498a-7601-4ea8-993d-c0f883457ee9
Route
TOPICAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (100 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-10-24 Until 2026-08-31

Description

Drug Facts

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Use:

Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect from the drying effect of wind and cold weather.

Section 42229-5

Drug Facts

Section 43683-2

Removed information from the directions section that is not applicable to the directions.

Section 50565-1
  • Keep out of reach of children.
  • If swallowed get medical help or contact Poison Control Center right away.
  • If redness or swelling develops consult a physician promptly.
Section 50566-9
  • Stop use and ask a doctor if conditions does not improve or lasts more than 7 days.
Warnings:

For external use only. Do not use on: deep and puncture wounds lacerations or infections serious burns animal bites.

Directions:

Apply as often as necessary.

Active Ingredients

Petrolatum 100%

Principal Display Panel Tube Label

NDC 65517-2020-1

DawnMist ®

INCONTINENCE

Petroleum Jelly

MOISTURIZES DRY

CHAPPED SKIN

COMPARE TO ACTIVE INGREDIENTS

OF VASELINE ®

2 oz. (56 g)

Principal Display Panel 1oz Tube Label

NDC 65517-2020-5

DawnMist ®



INCONTINENCE

Petroleum Jelly

MOISTURIZES DRY CHAPPED SKIN

1 oz. (28 g)


Structured Label Content

Use:

Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect from the drying effect of wind and cold weather.

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Removed information from the directions section that is not applicable to the directions.

Section 50565-1 (50565-1)
  • Keep out of reach of children.
  • If swallowed get medical help or contact Poison Control Center right away.
  • If redness or swelling develops consult a physician promptly.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if conditions does not improve or lasts more than 7 days.
Purpose

Skin Protectant

Warnings:

For external use only. Do not use on: deep and puncture wounds lacerations or infections serious burns animal bites.

Directions:

Apply as often as necessary.

Active Ingredients

Petrolatum 100%

Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

NDC 65517-2020-1

DawnMist ®

INCONTINENCE

Petroleum Jelly

MOISTURIZES DRY

CHAPPED SKIN

COMPARE TO ACTIVE INGREDIENTS

OF VASELINE ®

2 oz. (56 g)

Principal Display Panel 1oz Tube Label (Principal Display Panel - 1oz Tube Label)

NDC 65517-2020-5

DawnMist ®



INCONTINENCE

Petroleum Jelly

MOISTURIZES DRY CHAPPED SKIN

1 oz. (28 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)