ADVANCED PETROLATUM- petrolatum ointment

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Disponible depuis:

Ultra Seal Corporation

DCI (Dénomination commune internationale):

PETROLATUM

Composition:

PETROLATUM 1 g in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

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.

Statut de autorisation:

OTC monograph final

Résumé des caractéristiques du produit

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._
----------
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
ADVANCED PETROLATUM
petrolatum ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42213-042
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
1 g in 1 g
INACTIVE INGREDIENTS
Ultra Seal Corporation
INGREDIENT NAME
STRENGTH
MINERAL OIL (UNII: T5L8T28FGP)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
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 INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
M016
04/05/2011
05/31/2023
LABELER -
Ultra Seal Corporation (085752004)
REGISTRANT -
Ultra Seal Corporation (085752004)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Ultra Seal Corporation
085752004
pack(42213-042)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Ultra Seal Corporation
944090448
pack(42213-042)
Revised: 12/2022