FAREWELL COLLECTION- antiseptic shower cream cream 
Paveemol Company Limited

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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Paveemol-Brisas Shower Cream Nut Label

Active Ingredient(s)

Benzalkonium chloride 0.05 %.

Purpose

Antiseptic

Use

To help reduce bacteria on hands.

Warnings

For external use only.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may 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.

Stop use and ask a doctor if irritation or rash occurs. These may 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 1 800-222-1222

Directions

Other information

Inactive ingredients

acrylates copolymer, aloe barbadensis leaf extract, chlorphenesin, cocamidopropyl betaine, disodium EDTA, glycerin, glycol distearate, maltodextrin, phenoxyethanol, polyquaternium-7, propylene glycol, purified water USP, shea butter, sodium benzoate, sodium coco-sulfate, sodium laureth sulfate, triethanolamine.

Package Label - Principal Display Panel

250 mL NDC : 12961-115-11250 mL NDC : 81892-115-11

FAREWELL COLLECTION 
antiseptic shower cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81892-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.05 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SHEA BUTTER (UNII: K49155WL9Y)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81892-115-11250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2021
Labeler - Paveemol Company Limited (660079138)
Establishment
NameAddressID/FEIBusiness Operations
Paveemol Company Limited660079138manufacture(81892-115)

Revised: 12/2022
Document Id: efd6d66b-4389-a968-e053-2995a90a2470
Set id: c560fa46-d76a-d1fe-e053-2995a90af23f
Version: 2
Effective Time: 20221214
 
Paveemol Company Limited