BABY FRESH SCENT PETROLEUM- white petroleum jelly

BABY FRESH SCENT PETROLEUM by

Drug Labeling and Warnings

BABY FRESH SCENT PETROLEUM by is a Otc medication manufactured, distributed, or labeled by Jell Pharmaceuticals Pvt Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

White Petrolatum USP (99.9 %)

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

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

Warnings

For External Use Only.

Do not useover deep or puncture wounds, infections or lacerations. Ask a doctor.

When using this productavoid contact with eyes.

Stop use and ask doctorif condition worsens or does not improve within 7 days.

Keep out of reach of childrenif swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply product as liberally, as often as necessary.

INACTIVE INGREDIENT

Inactive ingredients

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Universal Baby fresh Scent Petroleum
Jelly
Net Wt. 13 OZ (368 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY FRESH SCENT PETROLEUM 
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30400-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30400-703-01	170 g in 1 JAR; Type 0: Not a Combination Product	02/15/2022
2	NDC: 30400-703-02	226 g in 1 JAR; Type 0: Not a Combination Product	02/15/2022
3	NDC: 30400-703-03	368 g in 1 JAR; Type 0: Not a Combination Product	02/15/2022
4	NDC: 30400-703-04	510 g in 1 JAR; Type 0: Not a Combination Product	02/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/15/2022

Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(30400-703)