BABY 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 (99.9 %)

Purpose

Skin Protectant

Inactive Ingredient

Fragrance

Uses

Helps treat and prevent diaper rash.

Other Uses:

Temporarily protects minor cuts, scrapes and burns

  • Helps relieve cracked or chapped lips and skin
  • Helps protect from drying effects of wind and cold weather
  • Helps reduce the appearance of fine dry lines
  • May be used daily all over your body face and hands as needed

Directions

Apply as needed

Warnings

For External Use Only.

Keep out of reach of children

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

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

PRINCIPAL DISPLAY PANEL
Baby Petroleum Jelly
For all your moisturizing needs
Net Wt. 4 oz. (113 g)
4 onzas
PRINCIPAL DISPLAY PANEL - 8oz

BABY PETROLEUM 
white petroleum jelly
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52920-126
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.99 g  in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52920-126-25 45 g in 1 JAR
2 NDC:52920-126-26 100 g in 1 JAR
3 NDC:52920-126-27 113 g in 1 JAR
4 NDC:52920-126-28 170 g in 1 JAR
5 NDC:52920-126-29 198 g in 1 JAR
6 NDC:52920-126-30 225 g in 1 JAR
7 NDC:52920-126-31 283 g in 1 JAR
8 NDC:52920-126-32 368 g in 1 JAR
9 NDC:52920-126-33 450 g in 1 JAR
10 NDC:52920-126-34 500 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 10/01/2010
Labeler - Singhfam Corporation (019499958)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52920-126)

Revised: 10/2012
Document Id: a4eb8b73-c171-4307-ad77-7f83afe8a90a
Set id: 9584d2a3-838b-4ca8-b019-e6f95bd1bdce
Version: 1
Effective Time: 20121004
 
Singhfam Corporation