Antibacterial Mulit-purpose Wipes: Product Information

ANTIBACTERIAL MULIT-PURPOSE WIPES- benzalkonium chloride cloth
Skaffles Group Limited Liability Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredient

Benzalkonium Chloride 0.3%

Purpose

Antibacterial

USE

Decreases Bacteria on fur

Warning

For external use only.

Avoid Contact with eyes. Safe for dogs 8 weeks of age and older.

Keep out of reach of children.

Directions

Remove wipe from pouch and reseal to maintain freshness,

wipe down dog from back of neck to tail,carefully avoiding the eyes ,didpose of wipe in trash ,do not flush

Inactive ingredients

Inactive ingredients Water, Aloe Barbadensis Leaf Juice,
PEG-75 Lanolin, Quatermium-52, PEG-8 Dimethicone, Disodium
Cocoamphodiacetate, Disodium EDTA, Chamomilla Recutita
(Matricaria) Flower Extract, Potassium Sorbate, Phenoxyethanol,
Cetylpyridinium Chloride, Sodium Benzoate, Citric Acid.

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ANTIBACTERIAL MULIT-PURPOSE WIPES
benzalkonium chloride cloth
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:77720-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
QUATERNIUM-52
PEG-75 LANOLIN
ALOE VERA LEAF
CITRIC ACID MONOHYDRATE
CETYLPYRIDINIUM CHLORIDE
PEG-8 DIMETHICONE
DISODIUM COCOAMPHODIACETATE
DISODIUM EDTA-COPPER
CHAMOMILE
POTASSIUM SORBATE
PHENOXYETHANOL
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77720-004-01 20 NOT APPLICABLE in 1 POUCH contains a NOT APPLICABLE
1 4.05 g in 1 NOT APPLICABLE This package is contained within the POUCH (77720-004-01)
2 NDC:77720-004-02 30 NOT APPLICABLE in 1 POUCH contains a NOT APPLICABLE
2 4.05 g in 1 NOT APPLICABLE This package is contained within the POUCH (77720-004-02)
3 NDC:77720-004-03 50 NOT APPLICABLE in 1 POUCH contains a NOT APPLICABLE
3 4.05 g in 1 NOT APPLICABLE This package is contained within the POUCH (77720-004-03)
4 NDC:77720-004-04 50 NOT APPLICABLE in 1 CANISTER contains a NOT APPLICABLE
4 4.05 g in 1 NOT APPLICABLE This package is contained within the CANISTER (77720-004-04)
5 NDC:77720-004-05 100 NOT APPLICABLE in 1 POUCH contains a NOT APPLICABLE
5 4.05 g in 1 NOT APPLICABLE This package is contained within the POUCH (77720-004-05)
6 NDC:77720-004-06 75 NOT APPLICABLE in 1 CANISTER contains a NOT APPLICABLE
6 4.05 g in 1 NOT APPLICABLE This package is contained within the CANISTER (77720-004-06)
7 NDC:77720-004-07 75 NOT APPLICABLE in 1 POUCH contains a NOT APPLICABLE
7 4.05 g in 1 NOT APPLICABLE This package is contained within the POUCH (77720-004-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2020
Labeler — Skaffles Group Limited Liability Company (831115642)
Establishment
Name Address ID/FEI Operations
Zhejiang Qimei Commodity Co., Ltd 544331136 manufacture
Establishment
Name Address ID/FEI Operations
Lonza Guangzhou Nansha LTD 545328150 api manufacture

Revised: 07/2020 Skaffles Group Limited Liability Company

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