PURE PETROLEUM  COCONUT SCENTED- white petroleum jelly 
Singhfam Corporation

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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Pure Petroleum Coconut Scented Jelly

Active Ingredient

White Petrolatum USP (99.9 %)

Purpose

Skin Protectant

Uses

For the temporary protection of minor cuts, scrapes, burns and sunburn.

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 conditon 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 liberally, as often as necessary.

Inactive Ingredient

Fragrance

PRINCIPAL DISPLAY PANEL

Pure Petroleum Coconut Scented Jelly

Net Wt. 4 oz. (113g)

label

PURE PETROLEUM   COCONUT SCENTED
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52920-128-35100 g in 1 JAR; Type 0: Not a Combination Product
2NDC:52920-128-36113 g in 1 JAR; Type 0: Not a Combination Product
3NDC:52920-128-37170 g in 1 JAR; Type 0: Not a Combination Product
4NDC:52920-128-38226 g in 1 JAR; Type 0: Not a Combination Product
5NDC:52920-128-39283 g in 1 JAR; Type 0: Not a Combination Product
6NDC:52920-128-40368 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/10/2015
Labeler - Singhfam Corporation (019499958)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-128)

Revised: 8/2015
Document Id: 1d3411b5-96e4-2c0f-e054-00144ff8d46c
Set id: c9f1de9c-3bf5-4aa2-bbf9-4a0d5f29b909
Version: 1
Effective Time: 20150813
 
Singhfam Corporation