JELL WITH VITAMIN A D- lanolin, petrolatum ointment 
Jell Pharmaceuticals Pvt Ltd.

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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Vitamin A & D

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Diaper rash ointment

Skin protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor cuts, scrapes and burns ■ temporarily protects and relieve chapped,chafed or cracked skin or lips■ protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ for skin protectant use: ■ apply as needed ■ for diaper rash: ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

Inactive ingredients

cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

Package Label

Label

JELL  WITH VITAMIN A D
lanolin, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30400-215-201 in 1 BOX01/12/2022
1NDC:30400-215-0256.6 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:30400-215-101 in 1 BOX01/12/2022
2NDC:30400-215-0128.3 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:30400-215-301 in 1 BOX01/12/2022
3NDC:30400-215-0385 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:30400-215-401 in 1 BOX01/12/2022
4NDC:30400-215-04113.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/12/2022
Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt Ltd.726025211manufacture(30400-215)

Revised: 3/2022
Document Id: d976e5f0-1be6-d9c4-e053-2a95a90a44a4
Set id: d976e5f0-1be5-d9c4-e053-2a95a90a44a4
Version: 1
Effective Time: 20220305
 
Jell Pharmaceuticals Pvt Ltd.