BUDPAK BABY- talc powder
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 BABY POWDER

Active Ingredient

Talc 99%

Purpose
Skin Protectant

Uses
To help absorb excess moisture and keep your baby's skin soft and dry.

Warnings

For external use only.

Close tightly after use.

Do not use on broken skin.

Avoid contact with eyes.

Keep powder away from child’s face to avoid inhalation, which can cause breathing problems.

Keep out of reach of children

Children if swallowed get medical help or contact Poison Control Center right away.

Directions

Shake powder into your hand and smooth on to skin.

For Babies: Use after every bath and diaper change to make your baby’s skin soft and smooth. This product’s natural softness helps prevent chafing.

For Adults: Use every day to help feel soft, fresh and comfortable.

Storage

Store in a cool, dry place.

Inactive Ingredient

Fragrance, Magnesium Stearate.

PRINCIPAL DISPLAY PANEL

Budpak Baby Powder

NET WT. 22 OZ (623g)

label

BUDPAK BABY
talc powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:27293-034
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	0.9 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)

#	Item Code	Package Description
Packaging
1	NDC:27293-034-05	57 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:27293-034-06	113 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:27293-034-07	283 g in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:27293-034-08	397 g in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:27293-034-09	425 g in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:27293-034-10	623 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	07/07/2014	12/18/2015

Labeler - Budpak Inc. (183224849)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(27293-034)

Revised: 12/2015

Document Id: 272f6760-201f-0acf-e054-00144ff88e88

Set id: 326b9797-24db-47fa-bb7f-3e5a82db8833

Version: 2

Effective Time: 20151218

Budpak Inc.