BUDPAK PETROLEUM COCOA BUTTER- white petrolatum jelly 
Budpak 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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Budpak Petroleum Cocoa Butter Jelly

Active Ingredient

White Petrolatum USP  99.9%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only.

When using this product do not get into eyes

See a doctor if condition lasts more than 7 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 Poison Control Center right away.

Directions

Apply as needed.

Other Information

Store at 20°to 25°C (68° to 77°F).

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter,  Fragrance.

PRINCIPAL DISPLAY PANEL

Budpak Petroleum Cocoa Butter Jelly

White Petrolatum 99.9%

NET WT 0.5 OZ (14 g)

image of package label

BUDPAK PETROLEUM COCOA BUTTER 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-029-141 in 1 BOX
114 g in 1 TUBE
2NDC:27293-029-281 in 1 BOX
228 g in 1 TUBE
3NDC:27293-029-351 in 1 BOX
335 g in 1 TUBE
4NDC:27293-029-421 in 1 BOX
442 g in 1 TUBE
5NDC:27293-029-021 in 1 BOX
5113 g in 1 TUBE
6NDC:27293-029-031 in 1 BOX
6226 g in 1 TUBE
7NDC:27293-029-04453 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/14/2014
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-029)

Revised: 2/2014
Document Id: 0db451f5-a019-431a-87db-8c5a59ba5d32
Set id: 5f9c37eb-4cb7-48c8-b273-a1fc0dbb88ee
Version: 1
Effective Time: 20140214
 
Budpak Inc.