REMEDY ESSENTIALS- white petrolatum,zinc oxide paste

Remedy Essentials by

Drug Labeling and Warnings

Remedy Essentials by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

White Petrolatum 75%

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve chapped or cracked skin
• Temporarily protects minor cuts, scrapes, and burns
• Protects minor skin irritation associated with diaper rash and helps seal out wetness

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 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.

Directions

• For skin protection
• Apply as needed
• For diaper rash
• Change wet and soiled diapers promptly
• Cleanse area and allow to dry
• Apply as needed with each diaper change.

Other information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

Mineral oil

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

REMEDY ESSENTIALS 
white petrolatum,zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-097-44	113 g in 1 TUBE; Type 0: Not a Combination Product	11/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/14/2016

Labeler - Medline Industries Inc. (025460908)