PETROLATUM- white petrolatum jelly

United States - English - NLM (National Library of Medicine)

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Active ingredient:
White petrolatum USP (100%)
Available from:
Foodhold USA, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - temporarily protects minor: - cuts - scrapes - burns - temporarily protects and helps relieve chapped or cracked skin and lips - helps protect from the drying effected of wind and cold weather - deep or puncture wounds - animal bites - serious burns
Authorization status:
OTC monograph final
Authorization number:
41520-069-27, 41520-069-54

PETROLATUM- white petrolatum jelly

Foodhold USA, LLC

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.

----------

Care One 069.001/069AA

Active ingredients

White petrolatum USP (100%)

purpos e

Skin Protectant

Us e

temporarily protects minor: - cuts - scrapes - burns

temporarily protects and helps relieve chapped or cracked skin and lips

helps protect from the drying effected of wind and cold weather

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

Dis claimer

This product is not manufactured or distributed by Unilever, distributor of Vaseline

Adverse Reactions

DISTRIBUTED BY FOODHOLD U.S.A, LLC

LANDOVER, MD 20785 1-877-846-9949

2017 Ahold Licensing Sarl

QUALITY QUARANTEED OR YOUR MONEY BACK

069.001/069AA

principal display panel

CAREONE

Compare to Vaseline

Petroleum Jelly Original

PETROLEUM JELLY

WHITE PETROLATUM SKIN PROTECTANT

NET WT 13 OZ (368 g)

PETROLATUM

white petrolatum jelly

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41520 -0 6 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

1 g in 1 g

Foodhold USA, LLC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41520 -0 6 9 -54

10 6 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 7/15/19 9 2

2

NDC:41520 -0 6 9 -27

36 9 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 7/15/19 9 2

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 7/15/19 9 2

Labeler -

Foodhold USA, LLC (809183973)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

0 8 8 520 6 6 8

ma nufa c ture (41520 -0 6 9 )

Revised: 5/2020

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