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NDC 59088-0434-05 Capasil 20; 100 mg/mL; mg/mL Details

Capasil 20; 100 mg/mL; mg/mL

Capasil is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	59088-0434
Product ID	59088-434_b1a8e78c-57f0-1f3e-e053-2995a90acbd5
Associated GPIs	90809902603700
GCN Sequence Number	081930
GCN Sequence Number Description	methyl salicylate/menthol CREAM(ML) 10 %-2 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	49197
HICL Sequence Number	002583
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	Capasil
Proprietary Name Suffix	Pain Relieving
Non-Proprietary Name	Menthol, Methyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20; 100
Active Ingredient Units	mg/mL; mg/mL
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	PureTek Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59088-0434-05 (59088043405)

Pricing Information	N/A
NDC Package Code	59088-434-05
Billing NDC	59088043405
Package	59 mL in 1 JAR (59088-434-05)
Marketing Start Date	2020-10-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1a8e78c-57f0-1f3e-e053-2995a90acbd5 Details

Active ingredients

Menthol 2.0%………... Topical Analgesic

Methyl Salicylate 10%…Topical Analgesic

Purpose

Topical Analgesic

Keep out of reach of children.

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

Uses

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

Warnings

For external use only.

Do not

apply on wounds or damaged skin
bandage tightly

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive ingredients

Aloe Barbadensis(Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Borago Officinalis Seed

Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-alpha-tocopheryl

acetate, Eucalyptus Globulus Leaf Oil, Fragrance, Fructose, Phenoxyethanol,

Propylene Glycol, Squalane, Stearic Acid, Stearyl Alcohol, Sodium Hydroxide,

Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil.

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 20°-25°C (68°-77°F).

Label

INGREDIENTS AND APPEARANCE

CAPASIL PAIN RELIEVING

menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-434
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MENHADEN OIL (UNII: 1D8HWC57D0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PALMITIC ACID (UNII: 2V16EO95H1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE SEED OIL (UNII: F8XAG1755S)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FRUCTOSE (UNII: 6YSS42VSEV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-434-05	59 mL in 1 JAR; Type 0: Not a Combination Product	10/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/14/2020

Labeler - PureTek Corporation (785961046)

Revised: 10/2020

Document Id: b1a8e78c-57f0-1f3e-e053-2995a90acbd5

Set id: b1a8e78c-57f0-1f3e-e053-2995a90acbd5

Version: 1

Effective Time: 20201014