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NDC 71592-0001-86 Antiperspirant Wipe for Women 15 g/100g Details

Antiperspirant Wipe for Women 15 g/100g

Antiperspirant Wipe for Women is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by FlawlessWipes, LLC. The primary component is ALUMINUM CHLOROHYDRATE.

Product Information

NDC	71592-0001
Product ID	71592-001_6148c5e0-d631-4d8d-8972-123bedffff66
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiperspirant Wipe for Women
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum Chlorohydrate
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	15
Active Ingredient Units	g/100g
Substance Name	ALUMINUM CHLOROHYDRATE
Labeler Name	FlawlessWipes, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part350
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71592-0001-86 (71592000186)

Pricing Information	N/A
NDC Package Code	71592-001-86
Billing NDC	71592000186
Package	6 PACKET in 1 PACKAGE (71592-001-86) / 3 g in 1 PACKET (71592-001-85)
Marketing Start Date	2017-07-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a94d0d85-2537-424f-87c8-6aeade047800 Details

ACTIVE INGREDIENT

Aluminum Chlorohydrate 15%

Purpose

Antiperspirant

USES

Underarm antiperspirant to reduce perspiration and odor

WARNINGS

For external use only
When using this product avoid contact with eyes. in case of eye contact, flush thoroughly with water.
Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away

DIRECTIONS

Open packet, remove and unfold wipe, apply to underarm only, dispose of used wipe in the trash, do not flush.

Inactive ingredients

Water, polysorbate 20, Salvia Officinalis (Sage) Leaf Extract, Usnea Barbata (Lichen) extract, Tocopherol, Tocopheryl Acetate, PEG-180, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Fragrance

Pakaging

INGREDIENTS AND APPEARANCE

ANTIPERSPIRANT WIPE FOR WOMEN

aluminum chlorohydrate swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71592-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
USNEA BARBATA (UNII: D6DVA9TCAP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAGE (UNII: 065C5D077J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71592-001-86	6 in 1 PACKAGE	07/18/2017
1	NDC:71592-001-85	3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	07/18/2017

Labeler - FlawlessWipes, LLC (080676003)

Registrant - FlawlessWipes, LLC (080676003)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Wipes International, Inc.		161104729	manufacture(71592-001)

Revised: 7/2017

Document Id: 6148c5e0-d631-4d8d-8972-123bedffff66

Set id: a94d0d85-2537-424f-87c8-6aeade047800

Version: 1

Effective Time: 20170717