drug facts

drug facts
SPL v1
SPL
SPL Set ID 69f25881-d2f0-f20e-e053-2a91aa0ae258
Route
topical
Published
Effective Date 2013-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (76 g)
Inactive Ingredients
lanolin lavender oil light mineral oil vitamin a vitamin d

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-03-01

Purpose

Skin Protectant

Description

White Petroleum Jelly USP (76% w/w)


Medication Information

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash  ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

Purpose

Skin Protectant

Directions

 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Other Information

■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive Ingredients

lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

Description

White Petroleum Jelly USP (76% w/w)

Section 50565-1

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

Do Not Use On

■ animal bites ■ deep or puncture wounds ■ serious burns

Package Label

Active Ingredient

White Petroleum Jelly USP (76% w/w)

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 in a few days


Structured Label Content

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash  ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

Purpose

Skin Protectant

Directions

 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Other Information

■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive Ingredients (Inactive ingredients)

lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

Section 50565-1 (50565-1)

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

Do Not Use On (Do not use on)

■ animal bites ■ deep or puncture wounds ■ serious burns

Package Label

Active Ingredient

White Petroleum Jelly USP (76% w/w)

When Using This Product (When using this product)

■ do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)