HUMCO WINTERGREEN OIL- methyl salicylate liquid
Humco Holding Group, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Humco Wintergreen Oil

Drug Facts

Active Ingredient

Mathyl Salicylate 98% w/w minimum

Purpose

External Analgesic

Uses

For temporary relief of muscular aches and pains due to over exertion or fatigue.

Warnings

For external use only

Do not drink.

Do not apply undiluted.

Do not apply to wounds or damaged skin.

Avoid contact with eyes or mucous membranes.

In case of eye contact, wash eyes for 15 minutes. Get medical attention.

If swallowed, immediately rinse mouth with water, ingest milk, induce vomiting and get medical attention.

When using this product

Do not bandage tightly.

Apply in ointments, liniments or lotion preparations only.

Undiluted product may casue skin irritations or serious burns.

Discontinue use and ask a doctor if

Condition worsens or excessive irritation develops.

Symtoms persists for more than 7 days, or clear up and occur whitin a few days.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. In case of eye contact, flush eye with running water for 15 minutes, get medical attention.

Directions (Use 10 - 15% in ointments, liniments & lotions)

Adultand children 2 yrs. and older: appply 10 - 15 % preparation to the affected area not more than 4 times daily.

Children under 2 yrs. of age: consult a doctor before use.

Other information

One (1) mL of 98% Methyl Salicylate is equivalent to 1.4 g of acetylsalicylate acid in potency.

Inactive Ingredient

water

Package Principal Display Pannel

Label 2 fl oz

image description

HUMCO WINTERGREEN OIL
methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-1667
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	980 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-1667-16	473 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/14/2017	10/31/2019
2	NDC:0395-1667-92	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/14/2017	10/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/25/1998	10/31/2021

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Gruop, Inc.		825672884	label(0395-1667) , manufacture(0395-1667) , analysis(0395-1667) , pack(0395-1667)

Revised: 11/2017

Document Id: 5df25635-32b4-d6f3-e053-2a91aa0a3c21

Set id: ad821b26-7fb6-4cd3-a1e6-b22fc14e0380

Version: 2

Effective Time: 20171114

Humco Holding Group, Inc.