HEALTH SMART LAVENDER BABY PETROLEUM- white petroleum jelly 
Home Smart Products

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.

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Active Ingredient

White Petroleum (99.9%)

Purpose

Skin Protectant

Uses:

Warning:

For External Use Only.

Do not use on:

Stop use and ask doctor

Keep out of reach of children

Directions:

Apply as often as necessary.

Inactive Ingredients:

None.

PRINCIPAL DISPLAY PANEL

HEALTH SMART LAVENDER BABY PETROLEUM JELLY

NET WT. 8OZ. (226G)

PRINCIPAL DISPLAY PANEL

HEALTH SMART LAVENDER BABY PETROLEUM 
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-011-1950 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
2NDC:52862-011-20100 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
3NDC:52862-011-14113 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
4NDC:52862-011-21170 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
5NDC:52862-011-01226 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
6NDC:52862-011-22283 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
7NDC:52862-011-23368 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
8NDC:52862-011-24425 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
9NDC:52862-011-25450 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
10NDC:52862-011-26500 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/28/2013
Labeler - Home Smart Products (161872676)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-011)

Revised: 8/2020
Document Id: ac9d47aa-8ae6-51d5-e053-2a95a90a4823
Set id: 5828df37-2a42-4129-8e4e-d5ac9c4c9615
Version: 2
Effective Time: 20200811
 
Home Smart Products