Welmedix®

Welmedix®
SPL v4
SPL
SPL Set ID 551e6cce-7adc-4e98-baff-2703b83d7526
Route
TOPICAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (49 g) Zinc Oxide (15 g)
Inactive Ingredients
Apis Cerana Worker Secretion Betula Pubescens Bark Shea Butter Calendula Officinalis Flower Starch, Corn Soy Sterol Lanolin Panthenyl Ethyl Ether Paraffin Propylparaben .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-01 Until 2019-01-31

Description

Petrolatum 49% Zinc Oxide 15%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum 49% Zinc Oxide 15%

Uses
  • Protects against minor skin irritation due to diaper rash and helps seal out wetness
  • Helps treat and prevent diaper rash
Warnings

For external use only

Directions:

• Change wet and soiled diapers, garments and linens promptly • Cleanse the affected area and allow to dry • Apply cream liberally, as often as necessary, with each diaper, garment or linen change, especially at bedtime or any time when exposure to wet or soiled diapers, garments, linens, feces or urine may be prolonged

Active Ingredients

Petrolatum 49%

Zinc Oxide 15%

Other Information:

Store at 20-25° C (68-77° F)

Inactive Ingredients

(corn) starch, butyrospermum parkii (shea) butter, lanolin, beeswax, calendula oil, paraffin, betula alba (white birch) bark extract, panthenyl ethyl ether, propylparaben, glycine soja (soybean) oil, tocopheryl acetate

Stop Use and Ask Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel Tube

HEALS +

SHIELDS

Hospital

Grade

Welmedix® HomeCare

PRO

RAPID RELIEF

RASH CREAM

PETROLATUM 49%

ZINC OXIDE 15%

Immediately soothes

inflamed skin

Helps heal broken

and damaged skin

Thick barrier cream

seals out wetness

Net Wt 4 oz (113g)

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Protects against minor skin irritation due to diaper rash and helps seal out wetness
  • Helps treat and prevent diaper rash
Purpose

Skin Protectant

Warnings

For external use only

Directions:

• Change wet and soiled diapers, garments and linens promptly • Cleanse the affected area and allow to dry • Apply cream liberally, as often as necessary, with each diaper, garment or linen change, especially at bedtime or any time when exposure to wet or soiled diapers, garments, linens, feces or urine may be prolonged

Active Ingredients (Active ingredients)

Petrolatum 49%

Zinc Oxide 15%

Other Information:

Store at 20-25° C (68-77° F)

Inactive Ingredients (Inactive ingredients)

(corn) starch, butyrospermum parkii (shea) butter, lanolin, beeswax, calendula oil, paraffin, betula alba (white birch) bark extract, panthenyl ethyl ether, propylparaben, glycine soja (soybean) oil, tocopheryl acetate

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel Tube

HEALS +

SHIELDS

Hospital

Grade

Welmedix® HomeCare

PRO

RAPID RELIEF

RASH CREAM

PETROLATUM 49%

ZINC OXIDE 15%

Immediately soothes

inflamed skin

Helps heal broken

and damaged skin

Thick barrier cream

seals out wetness

Net Wt 4 oz (113g)

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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