WELMEDIX HOMECARE PRO FRAGILE SKIN PROTECTANT- petrolatum ointment

Welmedix HomeCare PRO Fragile Skin Protectant by

Drug Labeling and Warnings

Welmedix HomeCare PRO Fragile Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Welmedix LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Petrolatum 42%

Purpose

Skin Protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather
• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from wetness
• temporarily protects: minor cuts scrapes burns

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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 within a few days.

Keep out of reach of children

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

Directions:

For general skin protection: apply as needed.

For incontinence care: change wet and soiled diapers and garments promptly. Cleanse the affected area and allow to dry. Apply ointment liberally, as often as necessary, especially at bedtime or any time when exposure to wet, moist or soiled garments may be prolonged.

Other Information:

Store at 20-25° C (68-77° F)

Inactive ingredients

Aloe Barbadensis Leaf Extract, Calendula Oil, Ceresin, Cetyl Alcohol, Dimethicone, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydrogenated Coconut Oil, Hydrogenated Lanolin, Lanolin Alcohol, Mineral Oil, Phenoxyethanol, Sorbitan Sesquioleaste, Stearyl Alcohol, Water

Principal Display Panel

PROTECTS +
NOURISHES

Hospital
Grade

Welmedix®
HomeCare
PRO

FRAGILE SKIN
PROTECTIVE OINTMENT

PETROLATUM 42%

Protects fragile skin &
creates an environment
for healing

Soothes and helps
relieve dry, cracked
and irritated skin

Nourishes skin with
Aloe, Calendula Oil
and Coconut Oil

Net Wt 5 oz (142g)

Carton Label

INGREDIENTS AND APPEARANCE

WELMEDIX HOMECARE PRO FRAGILE SKIN PROTECTANT 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24330-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	42 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOY STEROL (UNII: PL360EPO9J)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24330-412-03	142 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2013
2	NDC: 24330-412-02	106 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2013

Labeler - Welmedix Llc (830387812)