ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol ointment
Universal Distribution Center LLC

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.

82716

ULTRA STRENGTH PAIN RELIEF BALM
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52000-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52000-063-24	18 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2017	01/01/2019

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

Labeler - Universal Distribution Center LLC (019180459)

Revised: 10/2019

Document Id: 963f5b40-79e6-518e-e053-2995a90ad87e

Set id: 574dfd30-4cae-c05b-e053-2a91aa0a0d8b

Version: 2

Effective Time: 20191031

Universal Distribution Center LLC