PURE PETROLEUM- petrolatum 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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Active ingredient

White Petrolatum USP (100 %)

Purpose

Skin Protectant

Uses

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

Warnings

For External Use Only.

Keep out of reach of children.

If swallowed get medical help or contact a poison control center immediately.

When using this product

Avoid contact with eyes.

Do not use on

  • serious burns
  • deep or puncture wounds
  • animal bites

See a doctor if condition lasts for 7 days.

Directions

Apply as needed.

Inactive ingredients

None

PRINCIPAL DISPLAY PANEL

100% PURE PETROLEUM JELLY
For all your moisturizing needs
Net Wt. 4 oz. (113g) 4 onzas

PRINCIPAL DISPLAY PANEL
100% PURE PETROLEUM JELLY
Net Wt. 8 fl. oz. (250g) 8 onzas

PURE PETROLEUM 
white petroleum jelly
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52920-121
Route of Administration TOPICAL DEA Schedule     
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:52920-121-01 225 g in 1 JAR
2 NDC:52920-121-16 45 g in 1 JAR
3 NDC:52920-121-17 100 g in 1 JAR
4 NDC:52920-121-18 113 g in 1 JAR
5 NDC:52920-121-19 170 g in 1 JAR
6 NDC:52920-121-20 198 g in 1 JAR
7 NDC:52920-121-21 283 g in 1 JAR
8 NDC:52920-121-22 368 g in 1 JAR
9 NDC:52920-121-23 450 g in 1 JAR
10 NDC:52920-121-24 500 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 03/10/2010
Labeler - Singhfam Corporation (019499958)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52920-121)

Revised: 10/2012
Document Id: 41514997-ced8-4066-b3dd-0f34dab78e88
Set id: c66ee098-8f62-4c4c-b1ab-5fef84f4b22a
Version: 2
Effective Time: 20121003
 
Singhfam Corporation