ULTRA STRENGTH PAIN RELIEF BALM ULTRA STRENGTH (camphor- synthetic and menthol ointment

Ultra strength pain relief balm by

Drug Labeling and Warnings

Ultra strength pain relief balm by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 11%	Topical Analgesic
Menthol 11%	Topical Analgesic

Uses

See outer packaging for full uses.

Warnings

For External Use Only

When using this product

• Use only as directed
• Avoid contact with eyes and mucous membranes
• Do not apply to wounds, damaged or irritated skin
• Do not bandage or cover with wrap or use heating pad
• Do not use 1 hour prior to bathing or within 30 minutes after bathing.

Stop use and ask a doctor if

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days
• Pain clears up and then recurs a few days later.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily
• For children 12 years of age or younger, consult a doctor before use.

Other information

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

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin base.

Questions

1-855-314-1850

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH PAIN RELIEF BALM   ULTRA STRENGTH
camphor (synthetic) and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	110 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	110 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
PADANG CASSIA OIL (UNII: 0E15252LIW)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-331-18	1 in 1 PACKAGE	09/10/2020
1		18 g in 1 JAR; 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	09/10/2020

Labeler - Velocity Pharma LLC (962198409)

Registrant - Velocity Pharma LLC (962198409)