ARMAND REGULAR STRENGTH ITCH STOPPING- diphenhydramine hydrochloride, zinc acetate cream

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

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Active ingredient:
Diphenhydramine hydrochloride 2%, Zinc acetate 0.1%
Available from:
Weeks & Leo
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Diphenhydramine hydrochloride...............Topical anagesic Zinc acetate..............................................Skin protectant temporarliy 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 due to poison: - ivy - oak - sumac
Authorization status:
OTC monograph not final
Authorization number:
11383-261-51

ARMAND REGULAR STRENGTH ITCH STOPPING- diphenhydramine hydrochloride, zinc

acetate cream

Weeks & Leo

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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Armand Regular Strength Itch Stopping Cream Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpos e

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Us es

temporarliy 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 due to poison:

sumac

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 a doctor before use

on chicken pox

on measles

When using this product

do not get into eyes

Stop use and ask a 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

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

Other Information

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

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate,

propylene glycol, propylparaben, purified water

Package Label

Armand REGULAR STRENGTH ITCH Itch relief CREAM

Relieves pain from insects bites & skin irritation

Topical Analgesic

Skin Protectant

Regular strength ITCH Itch relief CREAM

compare to the active ingredients in Benadryl ® Orignial strength itch stopping cream

Relieves Pain & Itch fast

Itch stopping Cream

ARMAND REGULAR STRENGTH ITCH STOPPING

diphenhydramine hydrochloride, zinc acetate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:1138 3-26 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

10 mg

in 1 g

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

ZINC CATION

1 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Weeks & Leo

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

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

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:1138 3-26 1-51

1 in 1 CARTON

0 3/17/20 14

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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 3/17/20 14

Labeler -

Weeks & Leo (005290028)

Registrant -

Weeks & Leo Co., Inc. (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Weeks & Leo Co ., Inc.

0 0 529 0 0 28

ma nufa c ture (1138 3-26 1)

Revised: 4/2019

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