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NDC 76420-0211-01 PainXIT 3; 10 g/100g; g/100g Details

PainXIT 3; 10 g/100g; g/100g

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

Product Information

NDC	76420-0211
Product ID	76420-211_e9ae267d-3173-c033-e053-2a95a90ab3f9
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	PainXIT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3; 10
Active Ingredient Units	g/100g; g/100g
Substance Name	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 76420-0211-01 (76420021101)

Pricing Information	N/A
NDC Package Code	76420-211-01
Billing NDC	76420021101
Package	113.4 g in 1 BOTTLE (76420-211-01)
Marketing Start Date	2022-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d356a001-372f-430e-9a75-4657ea36fdde Details

SPL UNCLASSIFIED SECTION

Drugs Facts

Active Ingredients

Methyl Salicylate………10.00%

Menthol…………………3.00%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Warning

For external use only.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or cover treated areas.

Do not use with heating pad.

Do not apply to open wounds or damages skin.

A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.

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

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

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

Directions

For adults apply directly to affected area. Repeat as necessary, but do not use more than 3-4 times daily.

Additional Information

Store at room temperature.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Principal Display Panel

NDC 76420-211-01

PainXIT

Pain Relief Cream

4 oz (113.4g)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

INGREDIENTS AND APPEARANCE

PAINXIT

methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-211-01	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/28/2022

Labeler - Asclemed USA, Inc (059888437)

Revised: 9/2022

Document Id: e9ae267d-3173-c033-e053-2a95a90ab3f9

Set id: d356a001-372f-430e-9a75-4657ea36fdde

Version: 1

Effective Time: 20220927