FDA Label for Ivermectin
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 117 G TUBE CARTON
Ivermectin Product Label
The following document was submitted to the FDA by the labeler of this product Walmart Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716
PRODUCT OF MACAO
Active Ingredient
Ivermectin 0.5%
Purpose
Lice treatment
Use
treats head lice
Warnings
For external use only. Use only on the scalp.
Do Not Use
- on children under 6 months of age
- near the eyes
- inside the nose, ear, mouth, or vagina
- on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Ask A Doctor Before Use If You
- have any skin conditions or sensitivities
- are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby.
- are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.
When Using This Product
- keep eyes tightly closed and protect eyes with a washcloth or towel
- if product gets into eyes, gently flush with water
- eye redness, soreness, or irritation can occur
- dandruff, dry skin, or burning sensation of the skin can occur
Stop Use And Ask A Doctor If
- breathing difficulty occurs
- eye irritation occurs
- skin or scalp irritation continues or infection occurs
- rash develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Important: Read warnings before use
- children 6 months of age to under 12 years of age: an adult should supervise use
- adults and children 6 months of age and over:
- all household members should be checked by another person for lice and/or nits (eggs)
- use a magnifying glass in bright light to help you see the lice and/or nits (eggs)
- use a tool, such as a comb or two unsharpened pencils to lift and part the hair
- look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
- examine small sections of the hair (1-2 inches wide) at a time
- unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
- if either lice or nits (eggs) are found, treat with product
- your hair and scalp must be DRY before applying product
- use the top of cap to break the tamper seal on the tube
- apply product directly to dry hair and scalp
- completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair
- use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining
- rub product throughout your hair
- it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
- allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with product.
- after 10 minutes, rinse product completely from your hair and scalp using only water
- after rinsing, dry and style as usual. Wait 24 hours before applying shampoo.
- wash your hands after applying product
- nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits
- this is a single use product. Discard tube after use.
- do not use again on the same person and same lice infestation without talking to a healthcare provider first
- if infestation continues, see a doctor for other treatments
- machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.
- after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.
Inspect
Treat
Wait and rinse
After treatment
Other Information
- TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.
- store at room temperature 68°-77°F (20°-25°C)
- do not freeze
- keep carton and see Consumer Information Leaflet and warnings before use
Inactive Ingredients
butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.
Questions?
1-888-287-1915
Principal Display Panel - 117 G Tube Carton
NDC 79903-154-01
equate™
Compare
to the active
ingredient
in Sklice®*
ORIGINAL
PRESCRIPTION
STRENGTH
Ivermectin
Lotion, 0.5%
Lice Treatment
Ivermectin Lotion
Kills Lice
Now available without
a prescription
One tube, one time,
10 minutes
No nit combing required
No second application
required
INCLUDES:
1 TUBE
NET WT 4 OZ (117 g)
* Please review the disclaimer below.