ANTIPERSPIRANT WIPE FOR WOMEN- aluminum chlorohydrate swab
FlawlessWipes, LLC

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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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

Label

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)