All-160 New

All-160 New
SPL v4
SPL
SPL Set ID b73a8fc9-fa00-774a-e053-2995a90afd1e
Route
TOPICAL
Published
Effective Date 2014-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (93 g)
Inactive Ingredients
Lanolin Vitamin A Vitamin D Light Mineral Oil Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-01

Description

White petrolatum USP (93% w/w)

Purpose

Skin Protection


Medication Information

Purpose

Skin Protection

Description

White petrolatum USP (93% w/w)

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

Warnings

For external use only

Directions

For Skin Protection and Diaper rash ■ apply as needed

Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

Do Not Use On

■ deep or puncture wounds ■ animal bites ■ serious burns

Package Label

Active Ingredient

White petrolatum USP (93% w/w)

Other Information

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

Inactive Ingredients

lanolin, lavender fragrance, light mineral oil, paraffin, vitamin A, vitamin D

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

Keep Out of Reach of Children

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


Structured Label Content

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 Protection

Warnings

For external use only

Directions

For Skin Protection and Diaper rash ■ apply as needed

Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

Do Not Use On (Do not use on)

■ deep or puncture wounds ■ animal bites ■ serious burns

Package Label

Active Ingredient

White petrolatum USP (93% w/w)

Other Information

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

Inactive Ingredients (Inactive ingredients)

lanolin, lavender fragrance, light mineral oil, paraffin, vitamin A, vitamin D

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

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


Advanced Ingredient Data


Raw Label Data

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