TOPICAL ANALGESIC- dermaline arnica menthol gel gel

Topical Analgesic by

Drug Labeling and Warnings

Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Dermaline USA Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Menthol 1%. Purpose: Topical Analgesic

Purpose

Topical Analgesic, Gel

Use

For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation.

Warnings

For external use only. Flammable. Keep away from fire or flames.

Avoid Contact with eyes. Do not bandage tightly.

Do not apply over large areas of the body.

Do not use

• on children under 16 years of age except on the advice of a physician.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Incase accidental ingestion, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 16 years of age and older: Wash the affected area with mild soap and warm

water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily.

Do not bandage tightly or apply to wounds or damaged skin.

Children under 16 yeats of age: consult a doctor.

Other information

• Store between 15-30C (59-86F)
• Do not expose to excessive heat.

Inactive ingredients

Arnica Extract, Camphor, Carbomer, Deionized Water, DMDM Hydatoin, Ethyl Alcohol, Eucalyptus Oil, Isopropyl Alcohol, Nonoxynol-9, polysorbate 20, propyleneglycol, Tea Tree Oil, Trirthanolamine.

Package Label - Principal Display Panel

141 g

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC 
dermaline arnica menthol gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82165-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
AMMONIUM NONOXYNOL-9 SULFATE (UNII: 8Y8LQ8CRCC)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TEA TREE OIL (UNII: VIF565UC2G)
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 940 (UNII: 4Q93RCW27E)
ARNICA MONTANA (UNII: O80TY208ZW)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82165-104-05	141 g in 1 JAR; Type 0: Not a Combination Product	05/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/10/2021

Labeler - Dermaline USA Corp (016069241)