BEST CHOICE VAPOR STEAM- camphor (synthetic) liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
Available from:
Valu merchandiser
Administration route:
RESPIRATORY (INHALATION)
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant temporarily relieves cough ocurring with a cold
Authorization status:
OTC monograph final
Authorization number:
63941-256-04

BEST CHOICE VAPOR STEAM- camphor (synthetic) liquid

Valu merchandiser

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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Best Choice Vapor Steam

Drug Facts

Active ingredient

Camphor 6.2%

Purpos e

Cough suppressant

Us e

temporarily relieves cough ocurring with a cold

Warnings

For external use only.

Flammable. Keep away from fire or flame.

For steam inhalation only.

Ask a doctor before use if you have

a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

cough that ocurs with too much phlegm (mucus)

When using this product, do not

heat

microwave

use near an open flame

take by mouth

direct steam from the vaporizer too close to the face

add to hot water or any container where heating water except when adding to cold water only

in a hot steam vaporizer. May cause splattering and result in burns.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or

headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. In case of eye exposure,

flush with water.

Directions

see important warnings under "When using this product"

adults & children 2 years & over:

use 1 tablespoon of solution for each quart of water or 1½ teaspoonful of solution for each pint of

water

add solution directly to cold water only in a hot steam vaporizer

follow manufacturer's directions for using vaporizer

breathe in the medicated vapors

use up to three times daily or as directed by a doctor

children under 2 years: ask a doctor

Other information

close container tightly and store at room temperature away from heat

Inactive ingredients

alcohol (78%), cedarleaf oil, dimethicone, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer

Tamper-evident: do not use if the imprinted seal under the cap is broken or missing.

Keep this carton. It has important information.

PRINCIPAL DISPLAY PANEL

Best Choice

Compare to the active ingredient in Vicks ® VapoSteam ®*

VAPOR STEAM

COUGH SUPPRESSANT

Contains CAMPHOR

Liquid Medication for Hot Steam Vaporizers

Relieves Cough to Help You Rest

CAUTION: NOT FOR INTERNAL USE

fl oz (118 mL)

BEST CHOICE VAPOR STEAM

camphor (synthetic) liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-256

Route of Administration

RESPIRATORY (INHALATION)

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)

0 .6 23 g

in 10 mL

Inactive Ingredients

Valu merchandiser

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

CEDAR LEAF O IL (UNII: BJ16 9 U4NLG)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

MENTHO L (UNII: L7T10 EIP3A)

NUTMEG O IL (UNII: Z1CLM48 9 48 )

PO LO XAMER 12 4 (UNII: 1S6 6 E28 KXA)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 39 41-256 -

1 in 1 CARTON

0 7/0 1/20 14

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

11/0 2/20 11

Labeler -

Valu merchandiser (868703513)

Registrant -

Weeks & Leo Co., Inc. (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Weeks & Leo Co ., Inc.

0 0 529 0 0 28

ma nufa c ture (6 39 41-256 )

Revised: 4/2019

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