Label: ECZEMA- oatmeal lotion/shampoo
- NDC Code(s): 52915-010-05, 52915-010-19
- Packager: ORGANIC & SUSTAINABLE BEAUTY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
Colloidal Oatmeal 1%Close
Temporarily protects and helps relieve minor skin irritation and itching due to:
- poison ivy, oak, or sumac
- insect bites
External use only.
When using this product
- patch test before use
- keep out of eyes
- clean with soap and water to remove
- to avoid slipping, use mat in tub or shower
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 Poison Control within the U.S. (1-800-222-1222)
- dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse.
- for extra cleansing, allow to sit for 30 seconds and then rinse.
- Other information
You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016Close
- Inactive ingredients
Water, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, sodium benzoate.Close
- PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label
safe ♥ natural ♥ fun
COLLOIDAL OATMEAL (CONTAINS GLUTEN)
SHAMPOO & BODYWASH
SKIN PROTECTANT • GENTLY CLEANSES SENSITIVE OR IRRITATED SKIN
DUE TO ECZEMA • HELPS HEAL & PROTECT DELICATE SKIN
NO SULFATES, STEROIDS OR ALCOHOL
NO ADDED FRAGRANCE
HAIR, FACE & BODY
• for babies • kids •
• sensitive adults •
562 mL / 19 Fl. Oz.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52915-010 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (OATMEAL) OATMEAL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water decyl glucoside lauryl glucoside quillaja saponaria bark glycerin allantoin calendula officinalis flower viola tricolor yucca schidigera root aloe vera leaf jojoba oil quinoa oil xanthan gum panthenol fytic acid gluconolactone sodium benzoate Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52915-010-19 562 mL in 1 BOTTLE, PUMP 2 NDC:52915-010-05 14 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 10/01/2012 Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)