Label: AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE- hydrocortisone cream
- NDC Code(s): 43136-103-01
- Packager: Tai Guk Pharm. Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 31, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
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
-
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
- Inactive Ingredients
- Questions or comments?
-
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)
-
INGREDIENTS AND APPEARANCE
AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETETH-20 (UNII: I835H2IHHX) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-103-01 1 in 1 CARTON 07/31/2019 1 57 g in 1 TUBE; Type 0: Not a Combination Product 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 Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(43136-103)