HYDRATING HEALING SKIN PROTECTANT- petrolatum ointment ointment

Hydrating Healing Skin Protectant by

Drug Labeling and Warnings

Hydrating Healing Skin Protectant by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Petrolatum 41%

Purpose

Skin protectant (ointment) Treatment or prevention of diaper rash

Uses

temporarily protects minor: cuts, scrapes, burns

temporarily protects and helps relieve chapped or cracked skin and lips

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

Warnings

For external use only

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.

Do not use on

deep or puncture wounds, animal bites, serious burns

Keep out of reach of children

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

Directions

apply as needed

for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.  Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

Do not use if safety seal is broken or missing

Inactive ingredients

Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol

Label

INGREDIENTS AND APPEARANCE

HYDRATING HEALING SKIN PROTECTANT 
petrolatum ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-853
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)	35 g  in 100 g
CERESIN (UNII: Q1LS2UJO3A)	7 g  in 100 g
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)	3 g  in 100 g
PANTHENOL (UNII: WV9CM0O67Z)	0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	13.8 g  in 100 g
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)	0.1 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-853-03	85 g in 1 TUBE; Type 0: Not a Combination Product	07/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/25/2016

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(59779-853)