JELL WITH VITAMIN A D- lanolin, petrolatum ointment

Jell by

Drug Labeling and Warnings

Jell by is a Otc medication manufactured, distributed, or labeled by Jell Pharmaceuticals Pvt Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

JELL  WITH VITAMIN A D
lanolin, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30400-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30400-215-20	1 in 1 BOX	01/12/2022
1	NDC: 30400-215-02	56.6 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 30400-215-10	1 in 1 BOX	01/12/2022
2	NDC: 30400-215-01	28.3 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 30400-215-30	1 in 1 BOX	01/12/2022
3	NDC: 30400-215-03	85 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 30400-215-40	1 in 1 BOX	01/12/2022
4	NDC: 30400-215-04	113.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/12/2022

Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(30400-215)