Harmon Face Values Baby Healing Ointment

HARMON FACE VALUES BABY HEALING ADVANCED THERAPY- petrolatum ointment
Delta Pharma Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Petrolatum (41%)

Purpose

Skin Protectant (ointment)

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

Warning
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 the reach of children.

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

Directions

Apply as needed

Inactive Ingredients

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

HARMON FACE VALUES BABY HEALING ADVANCED THERAPY
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66353-200
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Mineral Oil (UNII: T5L8T28FGP)
Ceresin (UNII: Q1LS2UJO3A)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
Panthenol (UNII: WV9CM0O67Z)
Glycerin (UNII: PDC6A3C0OX)
LEVOMENOL (UNII: 24WE03BX2T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66353-200-20	85 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/11/2012

Labeler - Delta Pharma Inc. (200161730)