UNIVERSAL PURE PETROLEUM- white petroleum jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Universal Distribution Center LLC

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 1 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Skin Protectant Use s - For the temporary protection of minor cuts, scrapes, burns and sunburn. - Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Authorization status:

OTC monograph final

Summary of Product characteristics

UNIVERSAL PURE PETROLEUM- WHITE PETROLEUM JELLY
UNIVERSAL DISTRIBUTION CENTER 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._
----------
UNIVERSAL PETROLEUM JELLY (REGULAR)
ACTIVE INGREDIENT
White Petrolatum USP (100 %)
PURPOSE
Skin Protectant
USES
For the temporary protection of minor cuts, scrapes, burns and
sunburn.
Helps to temporarily protect chafed, chapped, cracked or windburned
skin and lips.
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE over deep or puncture wounds, infections or lacerations.
Ask a doctor.
WHEN USING THIS PRODUCT avoid contact with eyes.
STOP USE AND ASK DOCTOR if condition worsens or does not improve
within 7 days.
KEEP OUT OF REACH OF CHILDREN if swallowed get medical help or contact
a Poison
Control Center right away.
DIRECTIONS
Apply product as liberally, as often as necessary.
INACTIVE INGREDIENTS
None
PRINCIPAL DISPLAY PANEL
UNIVERSAL PURE PETROLEUM JELLY
SKIN PROTECTANT
NET WT. 13 OZ (368 g)
UNIVERSAL PURE PETROLEUM
white petroleum jelly
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52000-005
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
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52000-005-
19
226 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
2
NDC:52000-005-
20
45 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
3
NDC:52000-005-
21
100 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
4
NDC:52000-005-
22
113 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
5
NDC:52000-005-
23
170 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
6
NDC:52000-005-
24
198 g in 1 JAR; Type 0: Not a Combination
Product
11/07/2022
7
NDC:52000-005-
25
283 g in 1 JAR; Type 0: Not a Combination