AVON HeXashield Anti Itch Cream with Healing Aloe: Package Insert and Label Information

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.

Active Ingredient

Hydrocortisone 0.5 %

Purpose

Anti-Itch

Uses

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

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

Sensitive Skin

Hydrocortisone Cream

REGULAR STRENGTH

Anti-Itch Cream

NET WT 2 oz (57 g)

AVON ANTI ITCH CREAM WITH HEALING ALOE_1
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AVON ANTI ITCH CREAM WITH HEALING ALOE_DF
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AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARYL ALCOHOL
WATER
ALOE VERA LEAF
BUTYLATED HYDROXYTOLUENE
SORBITAN MONOSTEARATE
CETETH-20
CETYL ALCOHOL
MINERAL OIL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43136-103-01 1 TUBE in 1 CARTON contains a TUBE
1 57 g in 1 TUBE This package is contained within the CARTON (43136-103-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/31/2019
Labeler — Tai Guk Pharm. Co., Ltd. (689060246)
Establishment
Name Address ID/FEI Operations
Tai Guk Pharma. Co., Ltd. 689060246 manufacture (43136-103)

Revised: 07/2019 Tai Guk Pharm. Co., Ltd.

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