HEALTH SMART BABY PETROLEUM- white petroleum jelly

Health Smart Baby Petroleum by

Drug Labeling and Warnings

Health Smart Baby Petroleum by is a Otc medication manufactured, distributed, or labeled by Home Smart Products, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

White Petroleum (99.9%)

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses:

• Temporarily protects minor cuts, scrapes or burns.

• Temporarily protects and helps relieve chapped or cracked skin and lips.

• Helps protect from the drying effects of wind and cold weather.

WARNINGS

Warning:

For External Use Only.

DO NOT USE

Do not use on:

• deep or puncture wounds
• lacerations or infections
• serious burns
• animal bites

STOP USE

Stop use and ask doctor

• if condition does not improve or lasts more than 7 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• if swallowed get medical help or contact Poison Control Center right away.
• if redness or swelling developes, consult a physician promptly.

DOSAGE & ADMINISTRATION

Directions:

Apply as often as necessary.

INACTIVE INGREDIENT

Inactive Ingredients:

None.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

HEALTH SMART BABY PETROLEUM JELLY

NET WT. 8OZ. (226G)

INGREDIENTS AND APPEARANCE

HEALTH SMART BABY PETROLEUM 
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-015
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-015-19	50 g in 1 BOTTLE	07/28/2013
2	NDC: 52862-015-20	100 g in 1 BOTTLE	07/28/2013
3	NDC: 52862-015-14	113 g in 1 BOTTLE	07/28/2013
4	NDC: 52862-015-21	170 g in 1 BOTTLE	07/28/2013
5	NDC: 52862-015-01	226 g in 1 BOTTLE	07/28/2013
6	NDC: 52862-015-22	283 g in 1 BOTTLE	07/28/2013
7	NDC: 52862-015-23	368 g in 1 BOTTLE	07/28/2013
8	NDC: 52862-015-24	425 g in 1 BOTTLE	07/28/2013
9	NDC: 52862-015-25	450 g in 1 BOTTLE	07/28/2013
10	NDC: 52862-015-26	500 g in 1 BOTTLE	07/28/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/28/2013

Labeler - Home Smart Products (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-015)