PAINZAWAY BALM- camphor ointment

Painzaway Balm by

Drug Labeling and Warnings

Painzaway Balm by is a Otc medication manufactured, distributed, or labeled by Indiana Botanic Gardens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor 4.0%

Purpose

external analgesic ointment

Uses:

Temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises or simple backache.

Warnings

For external use only.

Avoid contact with the eyes.

When using this product, do not:

heat

microwave

use near open flames

add to hot water or any container where heating water.

May cause splattering and result in burns.

Do Not

use on wounds or damaged skin

bandage tightly

Stop using and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult physician.

Other information

Any Questions? 1-800-644-8327

website: www.botanicchoice.com

Use only if seal is unbroken.

Inactive ingredients

White petrolatum, cassia oil, clove oil, siberian fir needle oil, cajeput oil, peppermint oil, natural beeswax.

SPL UNCLASSIFIED SECTION

Manufactured by: Indiana Botanic Gardens, Inc.

3401 W. 37th Avenue Hobart, IN 46342

PRINCIPAL DISPLAY PANEL

Painzaway Balm

Topical Analgesic

Net Wt. 2oz.

INGREDIENTS AND APPEARANCE

PAINZAWAY BALM 
camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
CAJUPUT OIL (UNII: J3TO6BUQ37)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
CLOVE LEAF OIL (UNII: VCA5491KVF)
PEPPERMINT OIL (UNII: AV092KU4JH)
YELLOW WAX (UNII: 2ZA36H0S2V)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-040-01	29 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10578-040-02	57 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	12/01/2001

Labeler - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	manufacture(10578-040)