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NDC 51009-0845-22 Toms of Maine Coconut Lavender Antiperspirant / Deodorant 220 mg/g Details

Toms of Maine Coconut Lavender Antiperspirant / Deodorant 220 mg/g

Toms of Maine Coconut Lavender Antiperspirant / Deodorant is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Tom's of Maine, Inc.. The primary component is ALUMINUM CHLOROHYDRATE.

Product Information

NDC	51009-0845
Product ID	51009-845_b551413a-4516-4a67-bffc-788cf10583ef
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	Toms of Maine Coconut Lavender Antiperspirant / Deodorant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum chlorohydrate
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	220
Active Ingredient Units	mg/g
Substance Name	ALUMINUM CHLOROHYDRATE
Labeler Name	Tom's of Maine, Inc.
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 51009-0845-22 (51009084522)

Pricing Information	N/A
NDC Package Code	51009-845-22
Billing NDC	51009084522
Package	64 g in 1 CONTAINER (51009-845-22)
Marketing Start Date	2021-03-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5eed42c-e276-4941-8ca3-0e52e5d890aa Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Aluminum chlorohydrate (22%)

Purpose

Antiperspirant

Uses

reduces underarm wetness
48 hour protection

Warnings

For external use only

Do not use on broken skin

Ask doctor before use if you have kidney disease

Stop use if rash or irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (412-390-3381)

Directions

Apply to underarms only

Inactive ingredients

Elaeis guineensis (Palm) kernel oil, stearyl alcohol, dicaprylyl ether, hydrogenated soybean oil, hydrogenated castor oil, natural fragrance, Olea europaea (Olive) leaf extract, Cocos nucifera (Coconut) oil, maltodextrin

Questions?

1-800-FOR TOMS (1-800-367-8667)

SPL UNCLASSIFIED SECTION

DIST. BY TOM'S OF MAINE, INC.,

KENNEBUNK, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 64 g Container Label

48 HR

ODOR &

WETNESS

PROTECTION

PS0016520

NEW

LOOK

Certified

B

Corporation

THE ORIGINAL

Tom's

OF MAINE

COCONUT

LAVENDER

antiperspirant | deodorant

NATURAL

FRAGRANCE

aluminum chlorohydrate

2.25 OZ (64 g)

PS0015840

PRINCIPAL DISPLAY PANEL - 64 g Container Label

INGREDIENTS AND APPEARANCE

TOMS OF MAINE COCONUT LAVENDER ANTIPERSPIRANT / DEODORANT

aluminum chlorohydrate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51009-845
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PALM KERNEL OIL (UNII: B0S90M0233)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
COCONUT OIL (UNII: Q9L0O73W7L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51009-845-22	64 g in 1 CONTAINER; Type 0: Not a Combination Product	03/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part350	03/20/2021

Labeler - Tom's of Maine, Inc. (052764354)

Name	Address	ID/FEI	Business Operations
Establishment
Knowlton Development Corporation Inc		204006464	MANUFACTURE(51009-845) , ANALYSIS(51009-845)

Name	Address	ID/FEI	Business Operations
Establishment
Colgate-Palmolive Company		079342773	ANALYSIS(51009-845) , MANUFACTURE(51009-845) , PACK(51009-845) , LABEL(51009-845)

Revised: 5/2021

Document Id: b551413a-4516-4a67-bffc-788cf10583ef

Set id: b5eed42c-e276-4941-8ca3-0e52e5d890aa

Version: 1

Effective Time: 20210514

Search by Drug Name or NDC

NDC 51009-0845-22 Toms of Maine Coconut Lavender Antiperspirant / Deodorant 220 mg/g Details

Toms of Maine Coconut Lavender Antiperspirant / Deodorant 220 mg/g

Product Information

Package

Package Images

NDC 51009-0845-22 (51009084522)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b5eed42c-e276-4941-8ca3-0e52e5d890aa Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 64 g Container Label

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