ADVANCED PETROLATUM- petrolatum ointment
Ultra Seal Corporation

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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Drug Facts

Active Ingredients White Petrolatum 100%

Purpose: Skin Protectant

Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps chapped or cracked skin and lips. Helps protect lips from drying effects fo wind and cold weather.

For external use only. Do not use in eyes, on puncture wounds, animal bites, or serious burns or for more than one week unless directed by a doctor..

Stop use and ask a doctor if condition worsens, persists, or recurs.

Keep out of reach of children

Directions: Apply as needed

Inactive Ingredients: None

image description

ADVANCED PETROLATUM
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42213-042
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1 g in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42213-042-80	144 in 1 BOX	04/05/2011
1	NDC:42213-042-05	5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:42213-042-28	28 g in 1 TUBE; Type 0: Not a Combination Product	04/05/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	04/05/2011	05/31/2023

Labeler - Ultra Seal Corporation (085752004)

Registrant - Ultra Seal Corporation (085752004)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	pack(42213-042)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		944090448	pack(42213-042)

Revised: 12/2022

Document Id: f0fe66ff-926b-5b2a-e053-2995a90a90c4

Set id: f9164696-3128-4712-9276-e1d3e69dfd1b

Version: 6

Effective Time: 20221229

Ultra Seal Corporation