medpura

medpura
SPL v4
SPL
SPL Set ID 38cc2317-691b-4657-af05-c67623eba760
Route
topical
Published
Effective Date 2024-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (95 g)
Inactive Ingredients
cod liver oil lanolin mineral oil paraffin phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-13

Purpose

Skin Protectant

Description

White Petrolatum USP (95%)


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

■ 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

Other Information

store at 20°- 25°C (68°- 77°F).

Inactive Ingredients

cod liver oil (vitamin A and D), lanolin, mineral oil, paraffin wax, phenoxyethanol 

Description

White Petrolatum USP (95%)

Section 50565-1

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

Section 51945-4

Do Not Use On

■ animal bites ■ deep or puncture wounds ■ serious burns

Active Ingredient

White Petrolatum USP (95%)

Questions Or Comments?

 Call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma,Inc.

Fairfield, NJ 07004

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

■ 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

Other Information

store at 20°- 25°C (68°- 77°F).

Inactive Ingredients (Inactive ingredients)

cod liver oil (vitamin A and D), lanolin, mineral oil, paraffin wax, phenoxyethanol 

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 51945-4 (51945-4)

Do Not Use On (Do not use on)

■ animal bites ■ deep or puncture wounds ■ serious burns

Active Ingredient

White Petrolatum USP (95%)

Questions Or Comments? (Questions or comments?)

 Call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma,Inc.

Fairfield, NJ 07004

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)