Ling Nam Hak Kwai Oil by Ling Nam Medicine Factory (H.K.) Ltd. Ling Nam Hak Kwai Oil

Ling Nam Hak Kwai Oil by

Drug Labeling and Warnings

Ling Nam Hak Kwai Oil by is a Otc medication manufactured, distributed, or labeled by Ling Nam Medicine Factory (H.K.) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LING NAM HAK KWAI OIL- turpentine oil oil 
Ling Nam Medicine Factory (H.K.) Ltd.

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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Ling Nam Hak Kwai Oil

Drug Facts

Active Ingredients	Purpose
Turpentine oil 50%	External analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints due to:

• arthritis
• strains
• bruises
• sprains
• simple backache

Warnings

For external use only

Do not use

• on wounds
• irritated or damaged skin
• sensitive skin
• with a heating pad
• with, or at the same time as, other external analgesic products
• if allergic to any ingredients of this product
• if pregnant

When using this product

• avoid contact with the eyes or on mucous membranes
• do not bandage tightly
• do not apply to wounds or damaged skin
• do not use 1 hour before or after bathing

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation of the skin develops
• redness is present

If pregnant, ask health professional before use.

Keep out of reach of children to avoid accidental poisoning .

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

Do not use otherwise than as directed.

Directions

• Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: Do not use or consult a doctor.

Other information

• Store in a cool place
• Close tightly after each use

Inactive ingredients

Citronella Oil, Light Liquid Paraffin, Thyme oil

Questions?

+1-626-823-9933

M-F 9am to 5pm Pacific Time.

You may report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 2oz (60 mL)

NDC.No : 57598-222-02

LING NAM HAK KWAI OIL

EXTERNAL ANALGESIC

Ling Nam Medicine Factory (H.K.) Limited

Tuen Mun, New Territories, Hong Kong, China

Sole Distributor TCM Herbalway Inc., Covina, CA 91724, USA

LN HK_USA_Box.jpg

LING NAM HAK KWAI OIL 
turpentine oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57598-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G)	TURPENTINE	50 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
JAVA CITRONELLA OIL (UNII: DBD92X468R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
THYME OIL (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57598-222-02	1 in 1 BOX	11/11/2020
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/10/2020	02/01/2021

Labeler - Ling Nam Medicine Factory (H.K.) Ltd. (667152748)

Establishment
Name	Address	ID/FEI	Business Operations
Ling Nam Medicine Factory (H.K.) Ltd.		667152748	manufacture(57598-222)

Revised: 2/2021

Document Id: b6ff579a-5bce-3fe0-e053-2995a90a8c88

34390-5

Set id: 18bd2749-7a5c-4da1-8fea-51d94ed69eae

Version: 3

Effective Time: 20210203