CVS ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

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

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Active ingredient:
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
CVS
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for 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 Itch relief
Authorization status:
OTC monograph not final
Authorization number:
69842-952-02

CVS ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

CVS

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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CVS Extra Strength Itch Relief Spray

Active Ingredient

Diphenhydramine hydrochloride 2% Topical analgesic

Zinc acetate 0.1% Skin protectant

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

Directions

do not use more often than directed

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

Warnings

For external use only

Do not Use

on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth

Ask doctor Before use

on chicken pox

on measles

When using this product

do not get into eyes

Stop Use and ask physician

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.

Warning

for external use only

Purpos es

Itch relief

Inactive Ingredients

Purified Water, Glycerin, SD Alcohol, Povidone, Povidonee (K-30), Trolamine

Prinicpal dispaly panel

Diphenhydramine hydrochloride 2%

Topical analgesic

Zinc acetate 0.1% Skin protectant

Relieves Itch and Pain associated with insects bites & rashes due to posinon ivy Oak& sumac

CVS ITCH RELIEF

diphenhydramine hcl, zinc acetate spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-9 52

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC ACETATE (UNII: FM5526 K0 7A) (ZINC CATION - UNII:13S1S8 SF37)

ZINC ACETATE

0 .1 g

in 10 0 mL

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PO VIDO NE K3 0 (UNII: U725QWY32X)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 42-9 52-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/14/20 14

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

0 4/14/20 14

Labeler -

CVS (062312574)

Registrant -

Weeks & LEO, Inc. (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Weeks & Leo

0 0 529 0 0 28

ma nufa c ture (6 9 8 42-9 52)

Revised: 4/2019

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