drug facts

drug facts
SPL v1
SPL
SPL Set ID 2b4da9de-b3ef-4067-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5 g) camphor (natural) (3 g)
Inactive Ingredients
carbomer homopolymer type c polysorbate 60 aloe vera leaf aminomethylpropanol angelica archangelica root dmdm hydantoin hamamelis virginiana top imidurea isopropyl alcohol lavandin oil asian ginseng water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-04-01

Purpose

Topical Analgesic

Description

Camphor 3.00% Menthol 5.00%


Medication Information

Warnings
  • For external use only
  • Avoid contact with eyes and mucous membranes
Uses

Temporary relief from minor aches and pains of sore uscles and joints associated with:

  • arthritis
  • bursitis
  • simple backaches
  • sports injuries
  • strains of muscle and joint
Purpose

Topical Analgesic

Directions
  • Adults or children 2 years of age or older
  • Cleanse area - apply liberally over affected area as needed
  • Massage into skin until absorbed
  • Repeat up to 4 times a day
Other Information
  • Store in cool dry place
  • Minor separation may occur
  • Keep closed when not in use
  • Do not puncture of incinerate this packaging
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Angelica Archangelica Root Extract, Carbomer, DM DM Hydantoin, Hamamelis Virginiana (Witch Hazel) Extract, Imidazolidinyl Urea, Isopropyl Alcohol, Lavandula hybrida abrialis (Lavender) oil, Panax Ginseng Root Extract, Polysorbate 60, Water

Description

Camphor 3.00% Menthol 5.00%

Principal Display Panel

JIVAMUKTI®

CHINA-GEL®

White

Topical Pain Reliever

6 oz/170 g

Section 42229-5

Distributed by:

China-Gel, Inc.

Arlington Heights, IL 60005

For online orders, visit us at

www.jivamuktiyoga.com

212-353-0214

Do Not Use
  • with bandages or heating pad
  • with heat or open flame
  • on open wounds or open skin
  • with other topical products
  • if skin irritation occurs
Active Ingredients

Camphor 3.00%

Menthol 5.00%

Stop Use and Ask A Doctor If

pain persists more than 7 days, or returns within a few days

If Pregnant Or Breastfeeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

Warnings
  • For external use only
  • Avoid contact with eyes and mucous membranes
Uses

Temporary relief from minor aches and pains of sore uscles and joints associated with:

  • arthritis
  • bursitis
  • simple backaches
  • sports injuries
  • strains of muscle and joint
Purpose

Topical Analgesic

Directions
  • Adults or children 2 years of age or older
  • Cleanse area - apply liberally over affected area as needed
  • Massage into skin until absorbed
  • Repeat up to 4 times a day
Other Information (Other information)
  • Store in cool dry place
  • Minor separation may occur
  • Keep closed when not in use
  • Do not puncture of incinerate this packaging
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Angelica Archangelica Root Extract, Carbomer, DM DM Hydantoin, Hamamelis Virginiana (Witch Hazel) Extract, Imidazolidinyl Urea, Isopropyl Alcohol, Lavandula hybrida abrialis (Lavender) oil, Panax Ginseng Root Extract, Polysorbate 60, Water

Principal Display Panel

JIVAMUKTI®

CHINA-GEL®

White

Topical Pain Reliever

6 oz/170 g

Section 42229-5 (42229-5)

Distributed by:

China-Gel, Inc.

Arlington Heights, IL 60005

For online orders, visit us at

www.jivamuktiyoga.com

212-353-0214

Do Not Use
  • with bandages or heating pad
  • with heat or open flame
  • on open wounds or open skin
  • with other topical products
  • if skin irritation occurs
Active Ingredients

Camphor 3.00%

Menthol 5.00%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain persists more than 7 days, or returns within a few days

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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