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NDC 42406-0014-00 Fresh Sugar Roll-on Deodorant 150 mg/mL Details

Fresh Sugar Roll-on Deodorant 150 mg/mL

Fresh Sugar Roll-on Deodorant is a TOPICAL EMULSION in the HUMAN OTC DRUG category. It is labeled and distributed by Fresh Inc.. The primary component is ALUMINUM CHLOROHYDRATE.

Product Information

NDC	42406-0014
Product ID	42406-014_d0e9d12f-c4c3-26d2-e053-2a95a90ab2e5
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	Fresh Sugar Roll-on Deodorant
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALUMINUM CHLOROHYDRATE
Product Type	HUMAN OTC DRUG
Dosage Form	EMULSION
Route	TOPICAL
Active Ingredient Strength	150
Active Ingredient Units	mg/mL
Substance Name	ALUMINUM CHLOROHYDRATE
Labeler Name	Fresh Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part350
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42406-0014-00 (42406001400)

Pricing Information	N/A
NDC Package Code	42406-014-00
Billing NDC	42406001400
Package	1 BOTTLE, WITH APPLICATOR in 1 BOX (42406-014-00) / 75 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2015-09-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec1260b1-8967-4d94-a777-3ac30a0104bf Details

Drug Facts

Active ingredient

Aluminum Chlorohydrate 15%

Purpose

Antiperspirant

Use:

Reduces underarm perspiration

Warnings:

For external use only

Do not use

on broken skin.

Stop use and ask a doctor if

rash or irritation occurs.

Ask a doctor before use if you have

kidney disease.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply to underarms only

Inactive ingredients:

Aqua (Water), PPG-15 Stearyl Ether, Steareth-2, Steareth-20, Hamamelis Virginiana (Witch Hazel) Water, Avena Sativa (Oat) Kernel Extract, Spiraea Ulmaria Extract, Aloe Barbadensis Leaf Extract, Faex (Yeast Extract), Glyceryl Stearate, Butylene Glycol, Parfum (Fragrance), Sucrose, Propylene Glycol, BHT, Limonene, Citral, Linalool, Geraniol, Phenoxyethanol <06516/Z>

Package Labeling:

INGREDIENTS AND APPEARANCE

FRESH SUGAR ROLL-ON DEODORANT

aluminum chlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42406-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	150 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUCROSE (UNII: C151H8M554)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42406-014-00	1 in 1 BOX	09/18/2015
1		75 mL in 1 BOTTLE, WITH APPLICATOR; 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	09/18/2015

Labeler - Fresh Inc. (021403729)

Revised: 11/2021

Document Id: d0e9d12f-c4c3-26d2-e053-2a95a90ab2e5

Set id: ec1260b1-8967-4d94-a777-3ac30a0104bf

Version: 5

Effective Time: 20211116