EQUATE ANTIBACTERIAL HAND WITH MOISTURIZERS SPRING SHOWERS- benzalkonium chloride liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
WAL-MART STORES INC
INN (International Name):
BENZALKONIUM CHLORIDE
Composition:
BENZALKONIUM CHLORIDE 1.3 mg in 1 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
HELPS ELIMINATE BACTERIA ON HANDS
Authorization status:
OTC monograph not final
Authorization number:
49035-724-08

EQUATE ANTIBACTERIAL HAND WITH MOISTURIZERS SPRING SHOWERS-

benzalkonium chloride liquid

WAL-MART STORES INC

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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DRUG FACTS

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIBACTERIAL

USES

HELPS ELIMINATE BACTERIA ON HANDS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH WITH WATER

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY

DIRECTIONS

APPLY A SMALL AMOUNT ONTO WET HANDS. WORK INTO A LATHER AND RINSE

THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), COCAMIDOPROPYL BETAINE, HYDROXYETHYLCELLULOSE, GLYCERIN,

DECYL GLUCOSIDE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM),

POLYQUATERNIUM-7, POLOXAMER 124, TETRASODIUM EDTA, SODIUM CITRATE, CITRIC

ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI

42090), EXT. VIOLET 2 (CI 60730)

QUESTIONS OR COMMENTS?

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LABEL COPY

EQUATE ANTIBACTERIAL HAND WITH MOISTURIZERS SPRING SHOWERS

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-724

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

HYDRO XYETHYL CELLULO SE ( 50 0 0 CPS AT 1%) (UNII: X70 SE6 2ZAR)

GLYCERIN (UNII: PDC6 A3C0 OX)

DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PO LYQ UATERNIUM-7 ( 7 0 /3 0 ACRYLAMIDE/DADMAC; 16 0 0 0 0 0 MW) (UNII: 0 L414VCS5Y)

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

EDETATE SO DIUM (UNII: MP1J8 420 LU)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

EXT. D&C VIO LET NO . 2 (UNII: G5UX3K0 728 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-724-0 8

222 mL in 1 BOTTLE, PLASTIC

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 rt333E

0 8 /17/20 14

Labeler -

WAL-MART ST ORES INC (051957769)

Registrant -

APOLLO HEALT H AND BEAUT Y CARE (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

APOLLO HEALTH AND BEAUTY CARE

20 19 0 120 9

ma nufa c ture (49 0 35-724)

WAL-MART STORES INC

Revised: 8/2014

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