topcare everyday after sun cooling gel

topcare everyday after sun cooling gel
SPL v2
SPL
SPL Set ID baff7293-e1a3-d1f2-e053-2995a90a93ca
Route
topical
Published
Effective Date 2019-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
aloe vera leaf trolamine fd&c blue no. 1 polysorbate 80 diazolidinyl urea water menthol fd&c yellow no. 5 carbomer interpolymer type a (55000 cps) propylene glycol edetic acid isopropyl alcohol glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-12-05

Purpose

External Analgesic

Description

Lidocaine hydrochloride 0.5%


Medication Information

Warnings
  • For External Use Only
Uses

temporarily relieves pain and itching due to:

  • minor skin irritations
  • sunburn
  • minor burns
  • scrapes
  • minor cuts
  • insect bites
Purpose

External Analgesic

Directions
  • 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
Inactive Ingredients

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Description

Lidocaine hydrochloride 0.5%

Label

TopCare Everyday After Sun Cooling Gel

8 OZ (226 g)

NDC 36800-953-80

​do Not Use

​in large quantities, particularly over raw surfaces or blistered areas.

Active Ingredient

Lidocaine hydrochloride 0.5%

When Using This Product

  • avoid contact with eyes. If contact occurs, rinse with water to remove.
Stop Use and Ask A Doctor If

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings
  • For External Use Only
Uses

temporarily relieves pain and itching due to:

  • minor skin irritations
  • sunburn
  • minor burns
  • scrapes
  • minor cuts
  • insect bites
Purpose

External Analgesic

Directions
  • 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
Inactive Ingredients

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Label

TopCare Everyday After Sun Cooling Gel

8 OZ (226 g)

NDC 36800-953-80

​do Not Use (​Do not use)

​in large quantities, particularly over raw surfaces or blistered areas.

Active Ingredient

Lidocaine hydrochloride 0.5%

When Using This Product (When using this product)

  • avoid contact with eyes. If contact occurs, rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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