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NDC 76420-0201-01 Wasabi Rub .025; 10; 20 g/100g; g/100g; g/100g Details

Wasabi Rub .025; 10; 20 g/100g; g/100g; g/100g

Wasabi Rub is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is CAPSAICIN; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	76420-0201
Product ID	76420-201_e9bea956-f887-790d-e053-2995a90a5784
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	Wasabi Rub
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE, MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.025; 10; 20
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	CAPSAICIN; MENTHOL; METHYL SALICYLATE
Labeler Name	Asclemed USA, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76420-0201-01 (76420020101)

Pricing Information	N/A
NDC Package Code	76420-201-01
Billing NDC	76420020101
Package	113.4 g in 1 BOTTLE (76420-201-01)
Marketing Start Date	2022-03-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b2ef3215-2b82-47da-892f-dc9d3a53e985 Details

Active Ingredients

Methyl Salicylate 20.00%

Menthol 10.00%

Capsaicin 0.025%

Purpose

Topical Analgesic

Indications

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings

For external use only. Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. If swallowed, consult physician.

Do not apply on damaged or broken skin. Do not bandage tightly.

If pregnant or breast feeding, contact physician prior to use.

Directions

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Carbomer, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD&C Blue#1 and FD&C Yellow#5.

Principal Display Panel - Wasabi Rub Label

Wasabi Rub TM

Pain Relief  Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Principal Display Panel - Wasabi Rub Label

INGREDIENTS AND APPEARANCE

WASABI RUB

methyl salicylate, menthol, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-201-01	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/29/2022

Labeler - Asclemed USA, Inc. (059888437)

Revised: 9/2022

Document Id: e9bea956-f887-790d-e053-2995a90a5784

Set id: b2ef3215-2b82-47da-892f-dc9d3a53e985

Version: 2

Effective Time: 20220928