CAPSAICIN NO-FUSS APPLICATOR- capsaicin 0.15% liquid
Walgreens

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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WELL AT WALGREENS CAPSAICIN NO-FUSS APPLICATOR

Active ingredient Purpose

Capsaicin 0.15% Topical analgesic

Uses

Temporarily relieves minor pain associated with: • arthritis • simple backache • muscle sprains • bruises • cramps

Warnings

For external use only

When using this product

• Use only as directed • Do not bandage tightly

• Do not use with heating pad

• Avoid contact with eyes and mucous membranes

• Do not apply to wounds, damaged, broken or irritated skin

• A transient burning sensation may occur upon application but genetally disappears in several days

• If severe burning sensation occurs, discontinue use immediately and read package insert for important information

• Do not expose the area treated with product to heat or direct sunlight

• Avoid taking a bath or shower withing 1 hour before or after applying

Stop use and ask a doctor if

condition worsens
redness is present
irritation develops
symptoms last more than 7 days or clear up and occur again within a few days

Flammable keep away from fire or flame

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of the children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 18 years: • Apply to affected area

• Massage into painful area until thoroughly absorbed

• Repeat as necessary, but not more than 3 to 4 times daily

• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

•Children 18 years or younger: ask a doctor

Inactive ingredients

Carbomer, Glycerin, Propylene Glycol, SD 40-2 Alcohol (35%), Sodium Hydroxide, Water

Questions or comments?

1-866-2846

image description

CAPSAICIN NO-FUSS APPLICATOR
capsaicin 0.15% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3195
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Capsaicin (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	Capsaicin	1.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-3195-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2014	03/08/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/15/2014	03/08/2018

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(0363-3195) , label(0363-3195)

Revised: 3/2018

Document Id: 4e6c3474-6212-46d6-a189-53f6de5f3612

Set id: 0cbdb760-6ae7-4fc6-82b8-fbe8f7f7cd31

Version: 2

Effective Time: 20180312

Walgreens