PETROLEUM- white petrolatum jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

White Petrolatum USP (100%)

Available from:

Salado Sales, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant helps protect chapped skin - deep or puncture wounds - animal bites - serious burns

Authorization status:

OTC monograph final

Summary of Product characteristics

PETROLEUM- WHITE PETROLATUM JELLY
SALADO SALES, 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._
----------
PETROLEUM JELLY
069.001/069AA
ACTIVE INGREDIENTS
White Petrolatum USP (100%)
PURPOSE
Skin Protectant
USE
helps protect chapped skin
WARNINGS
For external use only
WHEN USING THIS PRODUCT
do not get into eyes
SEE A DOCTOR IF
condition 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.
DIRECTIONS
apply as needed
INACTIVE INGREDIENT
None
ADVERSE REACTIONS
Distributed by Salado Sales, Inc.
6201 NW H.K. Dodgen Loop Temple, TX 76504
saladosales.com
PRINCIPAL DISPLAY PANEL
CVP
100% PURE
PETROLEUM JELLY
WHITE PETROLATUM
SKIN PROTECTANT
NET WT 3.75 OZ (106 g)
PETROLEUM
white petrolatum jelly
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:57243-069
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
Salado Sales, Inc
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:57243-069-
54
106 g in 1 JAR; Type 0: Not a Combination
Product
06/04/2003
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
06/04/2003
LABELER -
Salado Sales, Inc (009830555)
REGISTRANT -
Vi-Jon, LLC (790752542)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Vi-Jon, LLC
088520668
manufacture(57243-069)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Vi-Jon, LLC
790752542
manufacture(57243-069)
Revised: 1/2023