BABY SOFT SCENT PETROLEUM- white petroleum jelly
Blue Cross Laboratories, Inc.

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

helps to soothe dry, chapped, cracked or irritated skin and lip due to cold and wind
for the temporary protection of minor cuts, scrapes, burns and sunburn

Warnings

For external use only

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

apply liberally, as often as necessary

Inactive ingredients

Fragrance

PRINCIPAL DISPLAY PANEL

BABY SOFT SCENT PETROLEUM JELLY
Skin Protectant
NET WT. 6 OZ (170 g)

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

BABY SOFT SCENT PETROLEUM
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:22431-706
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.99 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:22431-706-01	113 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
2	NDC:22431-706-02	170 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
3	NDC:22431-706-03	226 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
4	NDC:22431-706-04	270 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
5	NDC:22431-706-05	368 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/25/2019

Labeler - Blue Cross Laboratories, Inc. (008298879)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(22431-706)