PETROLATUM ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Henry Schein, Inc.

DCI (Denominação Comum Internacional):

PETROLATUM

Composição:

PETROLATUM 1 g in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

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.

Status de autorização:

OTC monograph final

Características técnicas

PETROLATUM- PETROLATUM OINTMENT
HENRY SCHEIN, 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._
----------
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
PETROLATUM
petrolatum ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0404-0042
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
INGREDIENT NAME
STRENGTH
MINERAL OIL (UNII: T5L8T28FGP)
PRODUCT CHARACTERISTICS
COLOR
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0404-0042-
47
144 in 1 BOX
06/08/2015
1
NDC:0404-0042-
05
5 g in 1 PACKET; Type 0: Not a Combination
Product
Henry Schein, Inc.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
M016
04/05/2011
04/01/2025
LABELER -
Henry Schein, Inc. (012430880)
REGISTRANT -
Ultra Seal Corporation (085752004)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Ultra Seal Corporation
085752004
pack(0404-0042)
Revised: 1/2023