SPL v1
SPL
SPL Set ID 9584d2a3-838b-4ca8-b019-e6f95bd1bdce
Route
TOPICAL
Published
Effective Date 2012-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.99 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-10-01

Description

Active Ingredient White Petrolatum USP (99.9 %)


Medication Information

Warnings and Precautions

Warnings

For External Use Only.

Indications and Usage

Use s

Helps treat and prevent diaper rash.

Dosage and Administration

Directions

Apply as needed

Description

Active Ingredient White Petrolatum USP (99.9 %)

Section 42229-5

Other Uses:

Temporarily protects minor cuts, scrapes and burns

  • Helps relieve cracked or chapped lips and skin
  • Helps protect from drying effects of wind and cold weather
  • Helps reduce the appearance of fine dry lines
  • May be used daily all over your body face and hands as needed
Section 50565-1

Keep out of reach of children

If swallowed get medical help or contact a poison control center immediately

Avoid contact with eyes

Section 50569-3

See a doctor

if condition lasts for 7 days

Section 50570-1

Do not use on

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

Inactive Ingredient

Fragrance

Section 51945-4

PRINCIPAL DISPLAY PANEL

Baby Petroleum Jelly

For all your moisturizing needs

Net Wt. 4 oz. (113 g)

4 onzas

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

White Petrolatum USP (99.9 %)


Structured Label Content

Indications and Usage (34067-9)

Use s

Helps treat and prevent diaper rash.

Dosage and Administration (34068-7)

Directions

Apply as needed

Warnings and Precautions (34071-1)

Warnings

For External Use Only.

Section 42229-5 (42229-5)

Other Uses:

Temporarily protects minor cuts, scrapes and burns

  • Helps relieve cracked or chapped lips and skin
  • Helps protect from drying effects of wind and cold weather
  • Helps reduce the appearance of fine dry lines
  • May be used daily all over your body face and hands as needed
Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed get medical help or contact a poison control center immediately

Avoid contact with eyes

Section 50569-3 (50569-3)

See a doctor

if condition lasts for 7 days

Section 50570-1 (50570-1)

Do not use on

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

Inactive Ingredient

Fragrance

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Baby Petroleum Jelly

For all your moisturizing needs

Net Wt. 4 oz. (113 g)

4 onzas

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

White Petrolatum USP (99.9 %)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)