MINERAL OIL LIGHT, N.F- mineral oil oil
GERITREX LLC

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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Mineral Oil

Active Ingredient:

Mineral Oil 100%

Use:

Helps treat and prevent diaper rash, protects chafted skin and seals out wetness.

Protects skin.

Keep out of reach of children

Caution: For External Use Only

In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately. Avoid contact with eyes. In case of accidental eye contactl flush eyes gently with water for 15 minutes. Obtain medical attention if irritation persists. If diaper rash worsens or does not improve consult a physician

Clean area thoroughly and allow to dry. Apply mineral oil liberally and as often as needed. Protects the skin against wetness.

Contains:

dl-alpha-tocopherol as preservative. Keep tightly closed and protect from direct sunlight.

Store at room temperature 15-30°C (59-86°F)

image description

MINERAL OIL LIGHT, N.F
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54162-185
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	471.99 g in 472 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)	0.00472 g in 472 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54162-185-16	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/31/2015

Labeler - GERITREX LLC (112796248)

Registrant - GERITREX LLC (112796248)

Name	Address	ID/FEI	Business Operations
Establishment
GERITREX LLC		112796248	manufacture(54162-185)