WALGREEN ANTI-ITCH- pramoxine hcl lotion

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

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Active ingredient:
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)
Available from:
Walgreens
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporary relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison: ivy oak sumac Anti - itch
Authorization status:
OTC monograph not final
Authorization number:
0363-0263-75

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WALGREEN ANTI-ITCH- pramoxine hcl lotion

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.

----------

Walgreen Sensitive Anti-Itch Lotion

Active Ingredients

Pramoxine HCl 1% External analgesic

Us es

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

dries the oozing and weeping of poison:

sumac

Warning

For external use only

Do not use

in the eyes or nose

over large areas of the body for prolonged periods

Ask doctor before use

on chicken pox

on measles

When using this product

do not get into eyes

Stop Use and ask doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Purpos e

Anti - itch

Directions

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredients

benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-

40 stearate,

PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum

Principal Display Panel

Walgreens

Compare to Sarna Sensitive Anti-Itch Lotion

Sensitive Formula Anti-Itch Lotion

Pramoxine Hydrochloride 1 percent

Steroid Free

Reduces and Relieves Itching associated with eczema, dry and sensitive skin

WALGREEN ANTI-ITCH

pramoxine hcl lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 26 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE -

UNII:0 6 8 X8 4E0 56 )

PRAMOXINE

HYDROCHLORIDE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL STEARATE/PEG-10 0 STEARATE (UNII: RD25J5V9 47)

WATER (UNII: 0 59 QF0 KO0 R)

DIMETHICO NE 3 50 (UNII: 2Y53S6 ATLU)

PEG-4 0 STEARATE (UNII: ECU18 C6 6 Q7)

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

PETRO LATUM (UNII: 4T6 H12BN9 U)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-0 26 3-

212 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 8 /20 20

Walgre e ns

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 rt348

12/0 8 /20 20

Labeler -

Walgreens (008965063)

Registrant -

Weeks & Leo, Inc. (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

WEEKS & LEO COMPANY, INC.

0 0 529 0 0 28

ma nufa c ture (0 36 3-0 26 3)

Revised: 12/2020

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