PEDI-BORO SOAK PAKS- aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
Pedinol Pharmacal, 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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Pedi-Boro® Soak Paks

Drug Facts

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.

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0884-1706-27	12 in 1 BOX; Type 0: Not a Combination Product	01/15/2013	12/31/2018
2	NDC:0884-1706-10	100 in 1 BOX; Type 0: Not a Combination Product	01/15/2013	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/15/2013	12/31/2018

Labeler - Pedinol Pharmacal, Inc. (064737125)

Registrant - Valeant Pharmaceuticals North America LLC (042230623)

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

Revised: 12/2018

Document Id: e78e638a-3b63-48a2-9ac2-1b29707d860d

Set id: ba30f107-6759-4190-b604-a68560c6c2ea

Version: 4

Effective Time: 20181204

Pedinol Pharmacal, Inc.