PEDI-BORO SOAK PAKS- aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution

Pedi-Boro Soak Paks by

Drug Labeling and Warnings

Pedi-Boro Soak Paks by is a Otc medication manufactured, distributed, or labeled by Pedinol Pharmacal, Inc., Valeant Pharmaceuticals North America LLC, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (in each packet)	Purpose
Aluminum sulfate tetradecahydrate, 1191 mg	Astringent*
Calcium acetate monohydrate, 839 mg	Astringent*
*When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.

Uses

Temporarily relieves minor skin irritations due to:

• poison ivy
• poison oak
• poison sumac
• insect bites
• athlete's foot
• rashes caused by soaps, detergents, cosmetics or jewelry

Warnings

For external use only

When using this product

• avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• do not cover compress or wet dressing with plastic to prevent evaporation
• in some skin conditions, soaking too long may overdry

Stop use and ask a doctor if

• condition worsens or symptoms last more than 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water
• stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.13% (1 packet), 0.26% (2 packets), or 0.41% (3 packets) aluminum acetate and is ready for use.

For use as a soak:

• soak affected area for 15 to 30 minutes as needed, or as directed by a doctor
• repeat 3 times a day or as directed by a doctor
• discard solution after each use

For use as a compress or wet dressing:

• soak a clean, soft cloth in the solution
• apply cloth loosely to affected area for 15 to 30 minutes
• repeat as needed or as directed by a doctor
• discard solution after each use

Inactive ingredient

mint green shade (FD&C Yellow No. 5 and FD&C Blue No. 1)

Questions or comments?

Please call 1-800-321-4576 or visit us at www.pedinaol.com

Retain this packaging for full directions and warnings.

SPL UNCLASSIFIED SECTION

Distributed by:
PEDiNOL, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 www.pedinol.com
Rev. 10/14

9428500

PRINCIPAL DISPLAY PANEL - 2.1 g packet

PEDiNOL®
pedi-boro®
soak pak

forms aluminum
acetate astringent solution

net wt. 2.1g

INGREDIENTS AND APPEARANCE

PEDI-BORO SOAK PAKS 
aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0884-1706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	615 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P)	1191 mg
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)	839 mg
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN (mint green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0884-1706-27	12 in 1 BOX; Type 0: Not a Combination Product	01/15/2013
2	NDC: 0884-1706-10	100 in 1 BOX; Type 0: Not a Combination Product	01/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/15/2013

Labeler - Pedinol Pharmacal, Inc. (064737125)

Registrant - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	MANUFACTURE(0884-1706)