Drug Labeling and Warnings

Drug Details [pdf]

ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol ointment 
Essentials Biotech Co, 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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Active ingredients Purpose

Camphor 11% ...........................................................................Topical analgesic

Menthol 11% ............................................................................Topical analgesic

Uses

temporary relief of minor aches and pains of muscles and joints related to arthritis, overexertion, simple backache, strains, and sprains

WARNING: EXTERNAL USE ONLY

When using this product

• Avoid contact with eyes and mucous membranes
• Do not apply to open wounds or damaged skin
• Do not bandage or use heating pad

STOP USE and consult a doctor if

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than seven days
• Pain clears up and then reoccurs a few days later

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Rub well on the affected area. Repeat 3 to 4 times daily
• Wash hands with soap and water after applying
• For children 2-12 years, consult a doctor before use

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive Ingredients

cajuput oil, clove oil, dementholized mint oil, paraffin, petrolatum

Distributed by:

Universal Distribution Center

Edison, NJ

www.universaldc.com

Made in P.R.C.

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71183-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.11 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.11 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
PETROLATUM (UNII: 4T6H12BN9U)
PEPPERMINT OIL (UNII: AV092KU4JH)
CLOVE OIL (UNII: 578389D6D0)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71183-063-24	18 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2017	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2017	01/01/2019

Labeler - Essentials Biotech Co, Ltd (544530742)

Revised: 11/2019

Document Id: 964e4a89-7d58-2faf-e053-2995a90a9c20

34390-5

Set id: 5fdca932-ed0d-34dd-e053-2991aa0a0939

Version: 4

Effective Time: 20191101