HUMCO MINERAL OIL LIGHT- mineral oil liquid

Humco Mineral Oil Light by

Drug Labeling and Warnings

Humco Mineral Oil Light by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Mineral Oil

Purpose

Skin Protectant

Use

Help treat and prevent diaper rash. Protects chafed skin due to diaper rash and, helps seal out wetness.

Warnings

For external use only. For internal use we suggest Humco Mineral Oil Heavy USP.

Avoid contact with eyes. In case of eye contact, flush eyes with running water for 15 minutes.

When using this product

Discontinue use if diaper rash worsens or does not improve and contact doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply mineral oil liberally as often as necessary, with each diapper change, especially at bed time or when exposure to wet diapers may be prolonged.

Inactive ingredient

dl-alpha tocopherol as a preservative.

Other information

Keep tightly closed and protect from direct sunlight.

Principal display panel

label

INGREDIENTS AND APPEARANCE

HUMCO MINERAL OIL LIGHT 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-1673
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1000 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-1673-28	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/25/1998

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-1673) , analysis(0395-1673) , pack(0395-1673) , label(0395-1673)