PAINZAWAY BALM

Main information

  • Trade name:
  • PAINZAWAY BALM- camphor ointment
  • Composition:
  • CAMPHOR (SYNTHETIC) 4 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PAINZAWAY BALM- camphor ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • external analgesic ointment Temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises or simple backache.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 10578-040-01, 10578-040-02
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

PAINZAWAY BALM- camphor ointment

Indiana Botanic Gardens

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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Painzaway Balm

Active Ingredient

Camphor 4.0%

Purpos e

external analgesic ointment

Us es :

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. 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.

Manufactured by: Indiana Botanic Gardens, Inc.

3401 W. 37th Avenue Hobart, IN 46342

Painzaway Balm

Topical Analgesic

Net Wt. 2oz.

PAINZAWAY BALM

camphor ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 578 -0 40

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

4 g in 10 0 g

Inactive Ingredients

Indiana Botanic Gardens

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

ABIES SIBIRICA LEAF O IL (UNII: XRY0 V4VZKZ)

CAJUPUT O IL (UNII: J3TO6 BUQ37)

CHINESE CINNAMO N O IL (UNII: A4WO0 6 26 T5)

CLO VE LEAF O IL (UNII: VCA549 1KVF)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

Product Characteristics

Color

YELLOW

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 578 -0 40 -0 1

29 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:10 578 -0 40 -0 2

57 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

12/0 1/20 0 1

Labeler -

Indiana Botanic Gardens (005421771)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Indiana Bo tanic Gardens

0 0 5421771

ma nufa c ture (10 578 -0 40 )

Revised: 10/2015