Label: ITCH FIXER- hydrocortisone cream
- NDC Code(s): 72663-493-66
- Packager: Welly Health PBC
- 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 February 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
-
Uses
For temporary relief of itching associated with minor skin irritations and rashes due to • eczema • insect bites • poison ivy • poison oak
• poison sumac • soaps • detergents • cosmetics • jewelry • seborrheic dermatitis • psoriasis • external feminine, genital and anal itching.
• Other uses of this product should be only under the advice and supervision of a doctor.
-
Warnings
For external use only.
Do not use: • for the treatment of diaper rash • for external genital itching – if you have a vaginal discharge, consult a doctor.
When using this product • avoid contact with eyes • do not begin the use of any other hydrocortisone product unless
you have consulted a doctor • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed
by a doctor. In case of bleeding, stop use, consult a doctor • do not put this product into the rectum by using fingers or any mechanical device or
applicator.
Stop use and ask a doctor if • condition worsens • If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of
this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
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Directions
Adults and children 2 years and older: • apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age • do not use. Consult a doctor. For external anal itching
• Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet
tissue or a soft cloth before application of this product.
• Children under 12 years with external anal itching: consult a doctor.
- Other information
- Inactive Ingredients
-
SPL UNCLASSIFIED SECTION
1% Hydrocortisone Anti-Itch Cream
FREE FROM
x
Petrolatum
Parabens
Sulfates
Mineral Oil
Fragrance
FRAGRANCE FREE
KID FRIENDLY
MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING
SQUEAKY CLEAN FIRST AID
Formulated with naturally derived plant-based ingredients
ALOE VERA known to help soothe skin
JOJOBA OIL known to help moisturize skin
HELPS PROVIDE TEMPORARY ITCH RELIEF FROM
skin irritation
rashes
insect bites
poison ivy
eczema
Packaging is recyclable.
Distributed by Welly Health PBC
Minneapolis, MN 55402
1-833-BE-WELLY | getwelly.com
Product of USA and Canada with globally sourced materials.
- Packaging
-
INGREDIENTS AND APPEARANCE
ITCH FIXER
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-493 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZOIC ACID (UNII: 8SKN0B0MIM) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) JOJOBA OIL (UNII: 724GKU717M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) OLEYL ALCOHOL (UNII: 172F2WN8DV) SORBIC ACID (UNII: X045WJ989B) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72663-493-66 1 in 1 CARTON 10/01/2021 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 10/01/2021 Labeler - Welly Health PBC (116766884)
