Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 32520d8f-91ee-47a1-9129-bf0746791f4b
Route
TOPICAL
Published
Effective Date 2013-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-02-05

Description

White Petrolatum, USP, 100% w/w

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White Petrolatum, USP, 100% w/w

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

For External Use Only.

Directions
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed
Do Not Use On
  • Deep or puncture wounds
  • Animal bites
  • Serious burns
Other Information
  • Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

Inactive Ingredients

None

Principal Display Panel

ProCure

PETROLATUM

JELLY

Skin Protectant

144

PACKETS

Net Weight: 5 grams

Item No. PCPJO5

When Using This Product
  • Do not get into eyes
Stop Use and Ask A Doctor If
  • The condition persists or gets worse
  • Symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Gram)

White Petrolatum, USP, 100% w/w


Structured Label Content

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

Skin Protectant

Warnings

For External Use Only.

Directions
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed
Do Not Use On (Do not use on)
  • Deep or puncture wounds
  • Animal bites
  • Serious burns
Other Information (Other information)
  • Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

Inactive Ingredients

None

Principal Display Panel

ProCure

PETROLATUM

JELLY

Skin Protectant

144

PACKETS

Net Weight: 5 grams

Item No. PCPJO5

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)
  • The condition persists or gets worse
  • Symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

White Petrolatum, USP, 100% w/w


Advanced Ingredient Data


Raw Label Data

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