AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE- hydrocortisone cream

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

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Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
Tai Guk Pharm. Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-Itch For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: - eczema - psoriasis - poison ivy, oak or sumac - insect bites - detergents - jewelry - cosmetics - soaps - seborrheic dermatitis - temporarily relieves external anal and genital itching - other uses of this product should be only under the advice and supervision of doctor
Authorization status:
OTC monograph not final
Authorization number:
43136-103-01

AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE- hydrocortisone cream

Tai Guk Pharm. Co., Ltd.

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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AVON HeXashield Anti Itch Cream with Healing Aloe

Active Ingredient

Hydrocortisone 0.5 %

Purpos e

Anti-Itch

Us es

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due

eczema

psoriasis

poison ivy, oak or sumac

insect bites

detergents

jewelry

cosmetics

soaps

seborrheic dermatitis

temporarily relieves external anal and genital itching

other uses of this product should be only under the advice and supervision of doctor

Warnings

For external use only.

Do not use

in the genital area if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with eyes

do not use more than directed unless told to do so by a doctor

do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if :

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few

days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

rectal bleeding occurs

Do not use this product and ask a doctor

if you have a vaginal discharge

before treating diaper rash

before using on children under 2 years of age

Keep out of reach of children.

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

Directions

for itching of skin irritation, inflammation, and rashes :

adults and children 2 years of age and older

apply to affected area not more than 3 to 4 times daily

children under 2 years of age: ask a doctor

for external anal and genital itching, adults :

when practical, clean the affected area with mild soap and warm water and rinse thoroughly

gently dry by patting or blotting with toilet tissue or a soft cloth before applying

apply to affected area not more than 3 to 4 times daily

children under 12 years of age: ask a doctor

Other information

store at room temperature

Lot No. & Exp. Date: see box or crimp of tube

Inactive Ingredients

aloe vera leaf, butylated hydroxytolune, ceteth-20, cetyl alcohol, methylparaben, mineral oil,

propylparaben, sorbitan monostearate, stearyl alcohol, water

Questions or comments?

Call toll free 1-800-FOR-AVON

www.avon.com

Principal Display Panel

HeXasheild

AVON

Relieves skin irritation and rashes due to

- Eczema - Seborrheic Dermatitis - Detergents

- Psoriasis - Poison ivy, Oak & sumac - Jewelry

- Insect bites - Soaps - Cosmetics

HeXashield

ANTI ITCH CREAM

WITH HEALING ALOE

Fragrance Free plus Soothing Aloe

0.5% hydrocortisone cream Regular strength

0.5% hydrocortisone cream Regular strength

Sensitive Skin

Hydrocortisone Cream

REGULAR STRENGTH

Anti-Itch Cream

NET WT 2 oz (57 g)

AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:43136 -10 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE (UNII: WI4X0 X7BPJ) (HYDROCORTISONE - UNII:WI4X0 X7BPJ)

HYDROCORTISONE

5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

WATER (UNII: 0 59 QF0 KO0 R)

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

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

CETETH-2 0 (UNII: I8 35H2IHHX)

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

MINERAL O IL (UNII: T5L8 T28 FGP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

Tai Guk Pharm. Co., Ltd.

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:43136 -10 3-0 1

1 in 1 CARTON

0 7/31/20 19

1

57 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 7/31/20 19

Labeler -

T ai Guk Pharm. Co., Ltd. (689060246)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tai Guk Pharma. Co ., Ltd.

6 8 9 0 6 0 246

ma nufa c ture (43136 -10 3)

Revised: 7/2019

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