Anti-Perspirant Deodorant Roll-On Alcohol-Free

Roll On Anti Perspirant by

Drug Labeling and Warnings

Roll On Anti Perspirant by is a Otc medication manufactured, distributed, or labeled by Hydrox Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROLL ON ANTI PERSPIRANT  ALCOHOL FREE- aluminum chlorohydrate solution 
Hydrox Laboratories

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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Anti-Perspirant
Deodorant Roll-On
Alcohol-Free

Drug Facts

Active ingredient

Aluminum Chlorohydrate, 10% - Anhydrous Basis

Purpose

Antiperspirant

Use

Reduces underarm wetness.

Warnings

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

Do not use on broken skin.

Stop use if rash or irritation occurs.

Ask a doctor before use if you have kidney disease.

If swallowed, get medical help or contact a Poison Control Center immediately. Use only as directed.

Directions

Apply to underarms. Use daily for best results.

Purified Water, Hydroxyethylcellulose, Glycerin, Polysorbate 20, Fragrance, Tetrasodium EDTA

MFG BY:
HYDROX LABORATORIES
825 Tollgate Rd. Elgin, IL 60123

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Label

Personal Care

Anti-Perspirant

Deodorant Roll-On
Alcohol-Free

Helps Reduce Wetness
Spring Fresh Fragrance

MADE IN USA

1.5 FL. OZ. (45mL)

ROLL ON ANTI PERSPIRANT   ALCOHOL FREE
aluminum chlorohydrate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10565-752
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 20 (UNII: 7T1F30V5YH)
Edetate Sodium (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10565-752-02	45 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	11/14/2017	03/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	11/14/2017	03/13/2020

Labeler - Hydrox Laboratories (025164302)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrox Laboratories		025164302	MANUFACTURE(10565-752) , label(10565-752) , pack(10565-752)

Revised: 3/2020

Document Id: 25efab62-9308-42e2-8b46-97322c4a0a57

34390-5

Set id: d5b3cea6-0ed0-4d6b-aea3-e2e7306db47d

Version: 2

Effective Time: 20200313

 

Hydrox Laboratories