Yours Baby Fresh Scent Petroleum Jelly

YOURS BABY FRESH SCENT PETROLEUM- white petrolatum jelly
TRANSWORLD INTERNATIONAL TRADING CORP.

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

Uses

Yous Petroleum Jelly is ideal for your baby's skin care needs.
Restores smooth and healthy skin.
Helps to treat and prevent your baby's delicate skin from diaper rash.
It works to seal out wetness.
Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind.

Warnings

For External Use Only.

When using this product

Avoid contact with eyes.

Stop use and ask a doctor

If condition worsens or does not improve after 7 days.

Keep out of reach of children

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

Directions

Cleanse and dry area, apply liberally, as often as necessary.

Inactive Ingredient

Fragrance

PRINCIPAL DISPLAY PANEL

YOURS BABY FRESH SCENT PETROLEUM JELLY

NET WT. 8OZ. (226 g)

label

YOURS BABY FRESH SCENT PETROLEUM
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71265-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g in 100 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71265-002-01	50 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
2	NDC:71265-002-03	113 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
3	NDC:71265-002-04	170 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
4	NDC:71265-002-05	226 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
5	NDC:71265-002-06	283 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
6	NDC:71265-002-07	368 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
7	NDC:71265-002-08	425 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
8	NDC:71265-002-09	450 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017
9	NDC:71265-002-10	500 g in 1 JAR; Type 0: Not a Combination Product	03/02/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/02/2017

Labeler - TRANSWORLD INTERNATIONAL TRADING CORP. (135417736)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(71265-002)