PETROLEUM JELLY- white petrolatum jelly

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
05-12-2022

Aktiv ingrediens:

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

Tilgjengelig fra:

Davion, Inc.

INN (International Name):

PETROLATUM

Sammensetning:

PETROLATUM 100 g in 100 g

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Skin Protectant - temporarily protects minor, cuts, scrapes, and burns - temporarily protects and helps relieve chapped or cracked skin and lips - Helps protect from the drying effects of wind and cold weather

Autorisasjon status:

OTC monograph final

Preparatomtale

                                PETROLEUM JELLY- WHITE PETROLATUM JELLY
DAVION, 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 INGREDIENT
WHITE PETROLATUM, USP (100%)
PURPOSE
Skin Protectant
USES
temporarily protects minor, cuts, scrapes, and burns
temporarily protects and helps relieve chapped or cracked skin and
lips
Helps protect from the drying effects of wind and cold weather
DIRECTIONS:
apply as needed
WARNINGS:
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not get into eyes.
SEE A DOCTOR IF
if condition worsens or lasts more than 7 days.
DO NOT USE ON
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
INACTIVE INGREDIENT
PRINCIPAL LABEL DISPLAY PANEL
NDC 42669-214-06
Perfect Purity
Pure Petroleum Jelly
GUARANTEED PURE 100% PURE
NET WT. 6 OZ. (170 g)
NDC 42669-214-13
Perfect Purity
Petroleum Jelly
Skin Protectant
For minor cuts, scrapes and burns
NET WT. 13 OZ. (369 g)
PETROLEUM JELLY
white petrolatum jelly
Davion, Inc.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42669-214
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
100 g in 100 g
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42669-214-
06
170 g in 1 JAR; Type 0: Not a Combination
Product
01/10/2017
2
NDC:42669-214-
13
369 g in 1 JAR; Type 0: Not a Combination
Product
01/10/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
01/10/2017
LABELER -
Davion, Inc. (174542928)
REGISTRANT -
Davion, Inc. (174542928)
Revised: 12/2022
                                
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